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

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

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

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

~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

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

~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

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

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,

– 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

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

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