Miele PG 8536 User manual

Operating instructions
Washer-Disinfector
PG 8536
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. 10 317 280
en-CA

2

Safety Instructions and Warnings ....................................6
Correct Use.....................................................6
Using Accessories ..............................................10
Symbols on the Washer-Disinfector .................................10
Disposing of Your Old Washer-Disinfector ............................10
Intended Use ....................................................11
User profiles......................................................12
Guide to the washer-disinfector .....................................13
Operating Controls ................................................14
Display Operation .................................................16
Example of a selection list ........................................16
Example of a program sequence display.............................17
Context menu ....................................................18
Change the display language ........................................19
Change the operating level ..........................................20
Start delay .......................................................22
Current faults .....................................................24
Reactivation ......................................................24
Opening and closing the door ......................................25
Electric door lock ..................................................25
Opening the door with the emergency release ...........................25
Water softener ...................................................26
Setting the water softener ...........................................27
Reactivation display................................................28
Refilling the softener with salt ........................................28
Filling the salt container ..........................................29
Inserting the salt container ........................................29
Executing the regeneration........................................30
Automatic mobile unit recognition...................................31
Spray arm monitoring .............................................32
Application ......................................................33
Protein testing ....................................................33
How to load the washer-disinfector ....................................34
Spring-loaded adapter for the water supply .............................35
How to adjust the upper basket.......................................35
Surgical Instruments ...............................................36
Ophthalmology ...................................................37
Contents
3

Anesthesia instruments (AN) .........................................38
Baby bottles......................................................39
OR shoes .......................................................40
Laboratory equipment ..............................................41
Chemical processes and technology.................................44
Adding liquid detergents and neutralizers ............................49
Dispensing systems................................................50
Message "Fill DOS [X] container" ...................................50
Adding liquid detergents and neutralizers ............................51
Message "Check dispensing system [X]" .............................52
Priming the dispensing system.....................................52
Operation .......................................................53
Turning on .......................................................53
Reset button ...................................................53
Starting a program.................................................53
Program sequence ................................................54
End of program ...................................................54
Turning off .......................................................54
How to cancel a program ...........................................55
Interrupting a program..............................................56
Process documentation ...........................................57
Maintenance of the washer-disinfector ...............................58
Routine maintenance ...............................................58
Process validation .................................................58
Routine checks ...................................................58
Cleaning the filters in the wash cabinet.................................59
Cleaning the coarse filter .........................................59
Cleaning the surface and micro-fine filters............................60
Cleaning the spray arms ............................................61
Cleaning the control panel...........................................62
Cleaning the exterior ...............................................62
Cleaning the wash cabinet ..........................................62
Cleaning the door seal..............................................62
Mobile units, baskets, and inserts .....................................63
Drying unit maintenance ............................................64
How to change the coarse filter ....................................64
How to change the fine filter .......................................65
Contents
4

Troubleshooting..................................................66
Temperature sensor................................................66
Cleaning the filters in the water inlet ...................................67
Customer service.................................................68
How to install the machine .........................................69
Electrical connection..............................................70
Water connection.................................................71
How to connect the water inlet .......................................71
DI water connection (pressure- resistant) for 60 - 1000 kPa pressure.......72
DI water connection (unpressurized) for 8.5 - 60 kPa (optional) ...........72
Connecting the water drain ..........................................73
Technical Data ...................................................74
Optional equipment ...............................................75
OXIVARIO and ORTHOVARIO Optional features .......................76
Intended Use .....................................................76
Applications ...................................................76
Safety instructions and warnings......................................77
Connecting the H2O2container .......................................77
Disposing of an old appliance ......................................78
Contents
5

This washer-disinfector complies
with all applicable safety laws and
regulations. However, inappropriate
use can lead to personal injury and
property damage.
Read the operating instructions
carefully before using this
washer-disinfector. This will help
keep you safe and avoid damage to
the washer-disinfector.
Keep these instructions in a safe,
accessible location.
Correct 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, is not permitted and may
be dangerous.
The cleaning and disinfection
processes described here apply only to
those instruments, medical products,
instruments and labware that are
specifically designed by the
manufacturer to be re-used. Always
comply with the product and instrument
manufacturer's instructions.
Miele will not be held liable for damage
caused by incorrect use of any kind.
~This washer-disinfector is intended
exclusively for stationary use in interior
locations.
To avoid possible injury, please
follow these instructions!
~This washer-disinfector should only
be installed, maintained, and repaired
by a Miele service technician. For best
compliance with Good Laboratory
Practice guidelines 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 the
danger of explosion or freezing may be
present.
~The electrical safety of this
washer-disinfector can only be
guaranteed 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 (for
example, electric shock).
~A damaged or leaking
washer-disinfector is is a hazard to your
safety. Immediately turn off the
washer-disinfector at the power switch
and contact the Miele Service
Department.
~Washer-disinfector operators must
be trained on a regular basis. Untrained
personnel must not be allowed access
to the washer-disinfector or its controls.
Safety Instructions and Warnings
6

~Always exercise caution when
handling the processing chemicals for
this washer-disinfector (detergent,
neutralizer, saponifier, rinsing agent,
etc.). These products can cause
irritation and burning.
Comply with the applicable safety
regulations! Use protective eyewear
and gloves. Always follow the
manufacturer's safety
recommendations when using process
chemicals (see material safety data
sheets).
~The washer-disinfector is designed
for use with water and designated
processing chemicals only. The
washer-disinfector must not be
operated with organic solvents or
flammable liquids. This may cause an
explosion or damage to rubber and
plastic components, which in turn
allows liquid substances to leak out.
~The water in the wash chamber is
NOT safe to drink.
~Do not sit or lean on an open door.
The washer-disinfector could tip up and
be damaged or cause an injury.
~Take care when sorting items with
sharp, pointed ends. Position them in
the washer-disinfector so that you will
not hurt yourself or create a danger for
others.
~When operating this
washer-disinfector, 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.
~The door seal and the operation of
the steam condenser should be
regularly checked, as volatile toxic or
chemical substances (e.g. aldehyde in
the disinfection agent) may be created
in the wash water during preparation.
Opening the door of the
washer-disinfector during a program
interruption therefore poses a major
risk.
~If you are exposed to toxic vapours
or processing chemicals, consult the
chemical manufacturer's material safety
data sheets for emergency procedures.
~Always allow mobile units, modular
baskets, inserts, and loads to cool
before removing. Be sure to empty any
water from concave items into the wash
chamber before removing.
~After drying with the drying unit,
leave the door open at first, to allow the
items 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.
~Do NOT 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.
Safety Instructions and Warnings
7

The following points should be
observed, to assist in maintaining
quality standards when processing
medical devices, instruments and
critical labware, to protect patients,
and to avoid damage to property!
~If the washer-disinfector 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 for
medical devices are being met.
Therefore, process results have to be
regularly tested and documented, both
thermo-electrically 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.
~The processing of medical devices
is carried out by means of thermal
disinfection.
The disinfection of other items that are
not heat-resistant (e.g. OR shoes) can
be carried out using the CHEM-DESIN
program with the addition of a chemical
disinfectant.
The disinfection parameters are based
on the recommendation of the
disinfectant manufacturer. Always
observe their specifications for
handling, applications and efficacy.
These chemo-thermal processes are
not suitable for processing medical
devices.
~Under certain circumstances, the
process chemicals can cause damage
to the washer-disinfector. It is
recommended to follow the
recommendations of the process
chemical manufacturers. In the event of
damages or concerns about possible
material incompatibilities, please
consult Miele.
~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 cleaning and disinfecting
results obtained. Pre-treatment agents
need to be completely removed before
placing the items in the
washer-disinfector.
~The process must be adjusted so
that no foam escapes the wash
chamber. Escaping foam jeopardizes
the safe operation of the
washer-disinfector.
Safety Instructions and Warnings
8

~The processing must be checked
regularly by the operator in order to
detect any foaming.
~To avoid damage to the
washer-disinfector and the associated
accessories by the effect of process
chemicals, introduced contamination or
their interaction, the instructions in the
chapter "Chemical Process
Technology" must be followed.
~Even when a chemical additive (e.g.
a cleaning agent) is recommended, the
washer-disinfector manufacturer takes
no responsibility for the effect of such
chemicals on the labware/instruments
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.
~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 Miele.
~In addition, for applications that
demand especially stringent cleaning
and rinsing results, (e.g., chemical
analysis) the operator must ensure that
quality control occurs on a regular
basis, to meet the standards involved.
~Only use mobile units, baskets, and
inserts as intended by the
manufacturer.
Hollow items must be positioned for full
exposure to rinse water.
~Empty all liquids from containers
and hollow items before loading them
into the washer-disinfector.
~Ensure that no acid or solvent
residues, especially hydrochloric acid
or chloride solutions, get inside the
wash chamber. Never place corroding
ferrous materials in the
washer-disinfector. Only trace amounts
of any organic solvents should be
present in any soiling.
~To avoid corrosive damage, make
sure the stainless steel housing does
not come into contact with
solutions/steam containing hydrochloric
acid.
~After any work on the water supply
system, the water lines to the
washer-disinfector must be bled.
Otherwise some components of the
washer-disinfector may be damaged.
~Please be sure to follow the
installation instructions in this manual
and in the installation manual.
Safety Instructions and Warnings
9

Using Accessories
~Whatever the application, only Miele
accessories should be connected to
this washer-disinfector. Consult Miele
for details on the type of equipment to
use.
~Only Miele mobile units, baskets,
and inserts should be used. If Miele
accessories are altered in any way, or
mobile units and inserts from another
manufacturer are used, Miele cannot
assure 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 or instruments and
the washer-disinfector itself are the
liability of the chemical manufacturer.
Symbols on the Washer-Disinfector
Caution:
Comply with the Operating
Instructions!
Caution:
Danger of electric shock!
Disposing of Your Old
Washer-Disinfector
~Any old washer-disinfector may be
contaminated by blood or other
pathogens, bodily fluids, etc., and
therefore must be decontaminated
before disposal.
For safety and environmental
protection, be sure to remove all
process chemical residue. (Comply
with safety regulations and Material
Safety Data Sheets, and wear
protective eyewear and gloves.)
Remove or inactivate the door latch, to
prevent children from locking
themselves inside. The
washer-disinfector can now be sent for
disposal through the proper resource
recovery facilities. For equipment 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 the Safety
Instructions.
Safety Instructions and Warnings
10

This Miele washer-disinfector is
designed to clean, rinse, disinfect and
dry re-usable medical devices,
laboratory devices and medical and
laboratory accessories.
Whatever items are being processed,
always comply with the particular
manufacturer's instructions
(EN ISO 17664 ; CAN/CSA-Z17664).
Typical applications include:
–surgical instruments,
–minimal invasive surgery instruments
(MIS),
– intensive care and anaesthesiology
equipment,
– baby bottles and nipples,
– OR shoes,
or
– laboratory equipment for research
and production,
–laboratory equipment for analytical
and preparation applications,
–microbiology and biotechnology
labware.
The type of laboratory glassware can
include anything from beakers, bottles,
centrifuge tubes, Erlenmeyer flasks,
funnels, pipettes, Petri dishes and
round bottom flasks.
In this operating manual, the general
term labware/instruments is used to
cover a range of equipment and items.
For standardized results, it is preferable
to machine-wash lab/surgical
instruments and equipment.
When disinfection is required to protect
staff and/or patients, the preference is
for thermal disinfection, e. g., with the
DES-VAR-TD process.
– An exception are temperature-
sensitive OR shoes which can be
processed using the CHEM-DESIN
program. –
According to the A0concept described
in EN ISO 15883-1 (CAN/CSA-Z15883),
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 A0
3000 includes the inactivation of HBV.
Regional and/or other official directives
like e. g., CSA Z314.8 Decontamination
of reusable Medical Devices are
applicable.
The cleaning parameters should always
be optimally matched to the type of
soiling and labware/instruments
involved.
The processing chemicals used also
should be matched to the particular
cleaning needs / analysis / analytical
methods involved.
Intended Use
11

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 DES-VAR-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 units, 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 15883-1
(CAN/CSA-Z15883), this
washer-disinfector is suitable for
process validation.
User profiles
Daily-routine operators
For daily routine tasks, the operating
personnel must be instructed in the
basic functions and the loading of the
washer-disinfector and should receive
regular training. Basic knowledge of the
machine-based processing of medical
devices is required.
Daily routine work takes place on
operating levels A and C.
Daily-routine supervisors
Advanced knowledge of the
machine-based processing of medical
devices is required for more complex
tasks such as program interruption or
program cancellation.
These tasks take place on operating
level B.
Service tasks and administration
Additional expertise is required for
changing the processes or adjusting
the washer-disinfector, e. g. the
accessories that are used or the site
conditions.
Validations require special expertise in
the machine-based processing of
medical products, in the processing
technology and the applicable
standards and legislation.
Service tasks and validations are
carried out on operating level D.
Intended Use
12

aElectronic controller
bInterfaces, rear panel
(upper left, behind cover plate)
cWater intake
dSensor access for validation
eFiller port for salt container
(water softener)
fFilter combination
gService panel
hContainers for DOS 2 and DOS 4
dispensing systems, optional
iDOS drawer
jContainers for neutralizer (red) and
liquid detergent (blue)
kDrying unit
lReset button
Guide to the washer-disinfector
13

Operating Controls
a(ON/OFF) sButton
Turns washer-disinfector on and off
bDoor Button a
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 a table of all the fault
numbers.
Guide to the washer-disinfector
14

dCustomer Service PC Interface 9
Test and transfer point for Customer Service
eButton h(Start button)
Starts the program
fButton +C (Clear button)
– return to the previous level
– discard entries in input fields
– Cancel the program
gand iButtons - e (Selection buttons)
– Shift position of marking in display
– changed marked value
– scroll
– Retrieve context menu
– display user-defined operating parameters during
program operation
hOK Button
– confirm marked menu item or selected value,
– acknowledge fault messages,
– acknowledge dialogue messages,
– Access A0graph during program operation,
– Viewing the temperature curve during the course of the
program sequence.
Guide to the washer-disinfector
15

Display Operation
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 Settings Jmenu, you can adjust the Profitronic
control system of the washer-disinfector to suit various
requirements. For additional information, please see the
Programming Manual.
Example of a selection list
Programme overview B
REACTIVATION
DES-VAR-TD
DES-VAR-TD-AN #
Use the - e buttons to move through the menu items.
The marking in the display can be moved using the -e
buttons.
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 -e selection
buttons, 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 -e selection buttons to display them.
A dashed line marks the end of the list. The last entry on the
list is above the line, the first entry is below it.
Guide to the washer-disinfector
16

Example of a program sequence display
DES-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 name
–the operating level
–the program segment
–the water temperature
(or the air temperature in the program segment "Dry")
– the estimated time remaining or the program time
completed so far
– any fault messages or notices
Guide to the washer-disinfector
17

Certain functions are available through the context menu at
any time, regardless of the operational level:
–Select display language
–Change operating level,
–Enter Start Delay.
In operating level D, current fault messages are also
displayed (if applicable).
^To enter the context menu, simultaneously press the - e
buttons for at least 3 seconds.
The context menu appears in the display:
Context menu B
Change display language F
Change operating level
Delay start #
Use the - e buttons to 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 sbutton or the main switch.
The language set in Settings / Language Jdoes not
change. This means that all reports and print-outs will
continue to be done in the system language.
^To select the menu item Change display language use
- e then activate it with OK.
The flag Jafter the text 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 selection in 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 selection by mobile unit
coding.
D Open program selection through the Program
overview, Programming and Settings Jmenu.
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 registered by Miele Service.
^Simultaneously press the - e buttons for at least 3
seconds.
The context menu appears in the display:
Context menu B
Change display language F
Change operating level
Delay start #
Context menu
20