Miele PWD 8531 WS Operating instructions
A
Operating instructions
WASHER-DISINFECTOR
PWD 8531 WS
It is essential to read these operating instructions
before installing and using the machine. This
prevents both personal injury and damage to the
machine.
en – C
Contents
Contents
GENERAL RULES ................................................................................................................................. 6
1.
1.1
Limitation of liability ...................................................................................................................... 6
1.2
Validity, content and storage ........................................................................................................ 6
2.PRODUCT INFORMATION .................................................................................................................... 7
2.1
Intended use ................................................................................................................................. 8
2.2
Authorization for service and user training ................................................................................... 8
2.3
Safety instructions and warnings ................................................................................................. 9
Appropriate use ........................................................................................................................ 9
Danger of injury ........................................................................................................................ 9
Quality assurance ................................................................................................................... 11
Using accessories .................................................................................................................. 12
Disposing of your old machine ............................................................................................... 13
Warning signs ......................................................................................................................... 13
2.4
Technical data ............................................................................................................................ 14
2.5
Recommendations for correct use ............................................................................................. 15
2.6
Training ....................................................................................................................................... 16
User profiles ............................................................................................................................ 16
3.INSTALLATION .................................................................................................................................... 17
3.1
Water connection ....................................................................................................................... 17
Water quality ........................................................................................................................... 17
Connecting the drain hose ..................................................................................................... 18
3.2
Electrical connection .................................................................................................................. 19
3.3
Installation site ventilation .......................................................................................................... 20
4.BUILT-IN WATER SOFTENER ............................................................................................................ 21
4.1
Refilling the salt .......................................................................................................................... 22
5.DISPENSING ....................................................................................................................................... 23
5.1
Volume flow control and lack of product ................................................................................... 23
5.2
Refilling process chemicals ........................................................................................................ 24
Warnings ................................................................................................................................. 25
6.OPERATION ........................................................................................................................................ 26
6.1
Checking consumption ............................................................................................................... 26
6.2
Opening and closing the door .................................................................................................... 27
Opening the door using the emergency release .................................................................... 28
6.3
Switching on and off ................................................................................................................... 28
6.4
Preparation ................................................................................................................................. 29
Preparing the load .................................................................................................................. 29
Preparing the machine ........................................................................................................... 31
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Contents
Checks at the end of a program ............................................................................................. 32
7.CONTROL PANEL AND SYMBOLS USED ......................................................................................... 33
7.1
Control panel .............................................................................................................................. 33
7.2
Buttons ....................................................................................................................................... 34
Buzzer ..................................................................................................................................... 34
7.3
Display ........................................................................................................................................ 35
8.PROGRAMS ........................................................................................................................................ 38
8.1
Starting a program ...................................................................................................................... 38
8.2
Program structure ....................................................................................................................... 39
8.3
Program sequence ..................................................................................................................... 40
9.MACHINE STATUS ............................................................................................................................. 41
9.1
Ready for operation .................................................................................................................... 41
9.2
Program ...................................................................................................................................... 41
9.3
Fault messages ........................................................................................................................... 41
9.4
Power failure ............................................................................................................................... 42
9.5
Resetting after fault messages ................................................................................................... 42
10.MENU ............................................................................................................................................. 43
10.1Entering the password ................................................................................................................ 43
10.2Setting the buzzer volume .......................................................................................................... 44
10.3Setting the date and time ........................................................................................................... 44
10.4Outputting the historical data ..................................................................................................... 45
10.5Selecting a language .................................................................................................................. 46
10.6Changing user names ................................................................................................................. 47
10.7Parameter overview .................................................................................................................... 48
11.HISTORICAL DATA ......................................................................................................................... 49
11.1Outputting batch protocols retrospectively................................................................................ 49
11.2External software ........................................................................................................................ 49
12.MESSAGES AND WARNINGS ....................................................................................................... 50
12.1List of warnings .......................................................................................................................... 50
12.2List of messages ......................................................................................................................... 51
13.PROCESS DOCUMENTATION ....................................................................................................... 52
13.1Serial interface ............................................................................................................................ 52
13.2User administration..................................................................................................................... 52
13.3USB port ..................................................................................................................................... 52
14.MAINTENANCE .............................................................................................................................. 53
14.1General recommendations on maintenance .............................................................................. 53
14.2Maintenance reminder ................................................................................................................ 53
14.3Routine maintenance work ......................................................................................................... 53
14.4Table of routine maintenance tasks ........................................................................................... 53
14.5Special maintenance .................................................................................................................. 58
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Contents
Table of special maintenance work ...................................................................................... 58
15.PROBLEMS – CAUSES – REMEDY ............................................................................................... 59
15.1Introduction................................................................................................................................. 59
15.2Problems (P) – Causes (C) – Remedy (R) ................................................................................... 59
16.DISPOSING OF YOUR OLD MACHINE .......................................................................................... 60
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GENERAL RULES
1. GENERAL RULES
The washer-disinfector is generally referred to as “the machine” in these operating
instructions. Reprocessable medical devices are referred to as the “load” if they are not more
closely defined.
1.1 Limitation of liability
The manufacturer shall not be held liable for faults or problems which arise due to tampering,
incorrect or improper use, and operation of the machine.
The operator must comply with all instructions set forth in the operating instructions, most
notably:
Always observe the intended use of the machine.
Required maintenance should always be performed promptly.
Use of the machine should be limited to persons who have been properly trained and
instructed.
Use only original spare parts.
Any modifications, adaptation or similar which may be made to machines which are
subsequently placed on the market do not oblige the manufacturer to intervene on previously
supplied machines, nor to consider the related operating instructions lacking and inadequate.
The operating instructions on the following pages are designed to guarantee the longevity
and functionality of your machine.
The instructions in this manual do not replace, but rather supplement employer requirements
to adhere to current legislation on standards of prevention and safety.
1.2 Validity, content and storage
It is important to keep these operating instructions with the machine for future reference.
If the machine is sold or transferred, the operating instructions must be handed over to the
new owner or users so that they can become acquainted with its functioning and the relevant
safety instructions and warnings.
It is essential to read these operating instructions before installing and using the
machine.
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2. PRODUCT INFORMATION
Compliance with safety standards allows the user to work with the machine without the risk
of harm.
Before starting work, the user must be completely familiar with the functions and proper
operation of the machine. The user must know the precise functions of all command and
control devices of the machine.
PWD 8531 WS
PRODUCT INFORMATION
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PRODUCT INFORMATION
2.1 Intended use
This machine is used to reprocess a wide range of reusable medical devices used for
dentistry. Follow all instructions issued by the instrument manufacturers (in compliance with
EN ISO 17664) and national legislation and guidelines relating to the machine-based
reprocessing of medical devices.
Medical devices such as dental instruments, saliva ejectors, handpieces, etc., which are
designated as reprocessable by the manufacturer, can be reprocessed in this machine.
The improper use of this machine is any use other than that for which the machine is
intended.
WARNING
Improper use can lead to personal injury and damage to property.
Miele cannot be held liable for damage resulting from incorrect or
improper use or operation.
Note: According to EN ISO 17664, the manufacturer of medical devices is obligated to
provide reprocessing instructions for their products. These must include instructions on how
medical devices are to be reprocessed, cleaned, disinfected, inspected, and stored. If,
during use, medical devices come into contact with blood or potentially contaminated
tissue, such devices must be reprocessed in compliance with national and local standards.
The machines are part of the process for reprocessing medical devices.
2.2 Authorization for service and user training
Miele & Cie. KG (hereinafter referred to as Miele) has been authorized by Steelco S.p.A, the
original equipment manufacturer, to provide technical training and user training for this
machine.
If reference is made in these operating instructions to Miele Service or an authorized service
technician, this is authorized by Steelco S.p.A as the manufacturer.
The machine may only be installed, commissioned, repaired, and maintained by Miele
Service or an authorized service technician.
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2.3 Safety instructions and warnings
This machine conforms to current safety requirements. Inappropriate use can, however,
lead to personal injury and material damage.
Read the operating instructions carefully before using this machine. This will prevent both
personal injury and damage to the machine.
Keep these operating instructions in a safe place.
Appropriate use
Use of the machine is only approved for the applications stated in the operating
instructions. Conversions, modifications, and any other use are not permitted and could
be dangerous.
The cleaning and disinfection processes are only designed for medical devices which are
designated as reprocessable by the instrument manufacturer. Instructions issued by load
and instrument manufacturers must be heeded.
Miele cannot be held liable for damage resulting from incorrect or improper use or
operation.
This machine is intended for indoor use in a stationary location only.
Danger of injury
Please pay attention to the following information to avoid injury:
The machine may only be installed, commissioned, repaired, and maintained by Miele
Service or an authorized service technician. A Miele service contract is recommended to
ensure full compliance with medical device regulations. Incorrect repairs can cause
considerable danger to users.
Do not install the machine in an area where there is any risk of explosion or of freezing
conditions.
In order to reduce the risk of water damage, the area around the machine should be
limited to furniture and fittings that are designed for use in commercial environments.
Some metal parts pose a risk of injury/being cut. Wear cut-resistant protective gloves
when transporting and setting up the machine.
The electrical safety of the machine can only be guaranteed when correctly grounded. It
is essential that this standard safety requirement is met. If in any doubt, please have the
on-site wiring system tested by a qualified electrician. Miele cannot be held liable for the
consequences of an inadequate grounding system (e.g. electric shock).
A damaged or leaking machine can pose a threat to your safety. Always switch off a
damaged or leaking machine immediately and call Miele Service.
Machine operators should be instructed on the use of the machine and trained regularly.
Untrained personnel must not be allowed access to the machine or its controls.
Only use process chemicals which have been approved by their manufacturer for the
relevant application. The manufacturer of the process chemicals is liable for any negative
influences on the material of the load and the machine.
Exercise caution when handling process chemicals. Some chemicals may be caustic,
irritating, and toxic.
The relevant safety regulations and safety data sheets issued by the process chemical
manufacturers must be observed.
Wear gloves and protective goggles.
The machine is only intended for use with water and suitable process chemicals. The use
of organic solvents or inflammable liquids is not permitted.
This could cause an explosion, damage rubber, or plastic components in the machine
and cause liquids to leak out of it.
PRODUCT INFORMATION
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PRODUCT INFORMATION
The water in the wash chamber must not be used as drinking water.
Do not lift the machine by protruding parts such as the door handle or the opened
service flap as these could be damaged or torn off.
Do not sit or lean on the opened door. This could cause the machine to topple over and
become damaged or cause you an injury.
Be careful 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.
Broken glass can result in serious injury when loading or unloading. Broken glass items
must not be processed in the machine.
Please be aware that the machine may be operating at high temperatures. Opening the
door by bypassing the safety lock can result in a risk of burning, scalding, or chemical
burns.
Should personnel accidentally come into contact with toxic vapours or process
chemicals, follow the emergency instructions given in the manufacturer's safety data
sheets.
Allow load carriers and the load to cool down before removing them. Any water
remaining in containers could still be very hot. Empty this water into the chamber before
removing items.
Never clean the machine or near vicinity with a water hose or a pressure washer.
The machine must be disconnected from the electricity supply before any maintenance
or repair work is carried out.
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Quality assurance
The following points should be observed to assist in maintaining quality standards
when reprocessing medical devices in order to protect patients and to avoid damage to
the loads being cleaned.
Only authorized personnel may interrupt a program in exceptional circumstances.
The standard of cleaning and disinfection in the disinfection programs must be routinely
confirmed by the operator. The process should be thermo-electrically tested on a regular
basis, and checked against documented control results.
For thermal disinfection, use temperatures and temperature holding times to achieve the
required infection prophylaxis in accordance with health and safety regulations.
Only reprocess undamaged and suitable items. When washing plastic items, ensure that
they are thermally stable. Nickel-plated items and items made of aluminum require
special procedures and are not generally suitable for machine reprocessing.
Items containing iron that can rust or corrode must not be added to the load or to the
wash chamber as contaminated items.
Under certain circumstances, process chemicals can result in damage to the machine.
Users are urged to follow the recommendations issued by manufacturers of process
chemicals.
Contact Miele in the event of damage and any suspicion of material incompatibility.
Instrument-care products based on paraffin oils (white oils) can damage the elastomers
and plastics in the machine. Such care products must not be dispensed as process
chemicals in this machine, even if they are recommended for machine use by the careproduct manufacturer.
Abrasive substances should not be introduced to the machine as these could cause
damage to mechanical components in the water circuit. Abrasive residues on the load
must be removed completely before reprocessing.
Pre-treatment with cleaning or disinfecting agents and certain types of soiling and
process chemicals can create foam. Foam can have an adverse effect on the disinfection
and cleaning result.
The reprocessing process must be set up to not result in foam being discharged from the
wash chamber. Foam discharge can compromise the operation of the machine.
The process used must be monitored on a regular basis by the operator to check
foaming levels.
Even when a process chemical, e.g. detergent, is recommended on technical application
grounds, Miele takes no responsibility for the effect of such chemicals on the load items.
Please note that changes in product formulation, storage conditions, etc., which are not
announced by manufacturers of process chemicals may impair the quality of cleaning
results.
PRODUCT INFORMATION
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PRODUCT INFORMATION
When using process chemicals, always consult the instructions issued by individual
manufacturers. Process chemicals must only be used for the purpose they are designed
for by the manufacturer to avoid any material damage or the occurrence of very strong
chemical reactions (e.g. oxyhydrogen explosion).
Always follow the relevant manufacturer's instructions on storage and disposal of
process chemicals.
Particles ≥ 0.8 mm are removed by the filters in the chamber. Smaller particles may find
their way into the circulation system. For this reason, reprocessing loads with narrow
lumens requires additional filtering of the wash water.
In critical applications where very stringent requirements have to be met, it is strongly
recommended that all the relevant factors for the process (detergent, water quality, etc.)
are discussed with Miele.
Load carriers which hold the load must be used only as intended.
The interior of lumened items must be thoroughly flushed through with wash water.
Place small and light items in a mesh tray for small items so that they do not block the
spray arms.
Empty any containers or utensils before loading them.
The amount of solvent residues on the load items must be minimal when they are placed
in the wash chamber.
Solvents with a flash point below 21°C may only be present in trace amounts.
Chloride solutions, in particular hydrochloric acid, or corrosive iron materials must not be
placed in the wash chamber.
Ensure that solutions or steam containing chlorides or hydrochloric acid do not come into
contact with the stainless steel outer casing of the machine in order to avoid any damage
through corrosion.
After any plumbing work, the water pipework to the machine will need to be vented. If
this is not done, components can be damaged.
The gaps between a built-in machine and adjacent cabinetry must not be sealed, e.g.
with silicone sealant, as this could compromise ventilation of the circulation pump.
Follow the installation instructions in the operating and installation instructions.
Using accessories
Only use genuine Miele original spare parts and accessories suitable for the application
they are required for. Model designations are available from Miele.
Only use Miele wash carts, baskets, modules, and inserts. Using wash carts, baskets,
and inserts made by other manufacturers, or making modifications to Miele accessories
can result in unsatisfactory cleaning and disinfection result. Any resultant damage would
not be covered by the warranty.
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Disposing of your old machine
Please note that the machine may contain contamination from blood and other bodily
fluids, pathogens, and facultative pathogens, and must be decontaminated before
disposal.
For environmental and safety reasons, dispose of all process chemical residues in
accordance with safety regulations (wear safety goggles and gloves).
Remove or disable the door lock prior to disposal of the machine, so that children cannot
become trapped inside. Then make appropriate arrangements for safe disposal of the
machine, see chapter 16 Disposing of your old machine for more details.
Warning signs
In order to inform users of their obligations and to warn of risks, the machine is equipped with
warning signs in accordance with valid legislation.
General warning signs
PRODUCT INFORMATION
Warning!
Danger of electric shock!
The evaluation of risks for the health and safety of operators carried out in the workplace and
on any equipment used, as well as the evaluation of residual risks as indicated, allow the
employer to evaluate the need to adopt the individual protection gear which is most suitable
and appropriate to be provided to the operators.
Miele cannot be held liable for damage or injury caused by noncompliance with the safety
instructions and warnings.
Observe the operating
Warning!
instructions!
Warning!
Hot surfaces!
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PRODUCT INFORMATION
2.4 Technical data
PWD 8531 WS
Imperial Metric
Width 22 7/16 (+2 15/16)" 570 (+ 75) mm
Depth with closed door 22 5/8" 575 mm
Height 21 1/16" 535 mm
Total weight 122 Ibs 55 kg
Wash chamber dimensions:
– Width
– Depth
– Height
Voltage, rated load, fuse rating See data plate and installation plan
Average sound pressure level < 70 dB (A)
Type of protection
(according to IEC 60529)
Operation: Temperature range +5 to +40°C
16 5/16"
18 7/8"
14 3/4"
IP21
Relative humidity range 20 to 90% without condensation
Maximum altitude: 2,000 m ASL
415 mm
480 mm
375 mm
Storage and transportation
conditions
Overvoltage category
(according to IEC EN 60664)
CE mark Health Canada Class II Medical Device
Manufacturer's address Steelco S.p.A
-5 to +50°C
20% to 90% without condensation
500 hPa to 1,060 hPa
II
Via Balegante, 27
31039 Riese Pio X (TV), Italy
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PRODUCT INFORMATION
2.5 Recommendations for correct use
The user must supervise the machine during the program.
Load carriers with injector connections must be connected to the water supply.
A running program must not be interrupted as this may compromise reprocessing
results.
The standard of cleaning and disinfection in the disinfection programs must be
routinely confirmed by the operator. The process should be thermo-electrically tested
on a regular basis, and checked against documented control results.
Only use process chemicals which have been approved by their manufacturer for the
relevant application. The manufacturer of the process chemicals is liable for any
negative influences on the material of the load and the machine.
Do not reprocess items containing substances which, in accordance with the current
legislation, must not be discharged into the sewage system. These substances must
be disposed of separately.
The machine is only intended for use with water and process chemicals.
The use of organic solvents or inflammable liquids is not permitted as there is a risk of
explosion. Such substances can also result in the premature wear on components.
Solvent residues, chloride solutions, and acids, particularly hydrochloric acid, can
damage steel components and must not be placed in the machine.
Do not use powder detergents.
Do not use domestic detergents.
Accessories which are not approved by the manufacturer may compromise
reprocessing results as well as user safety.
The user must carry out a general check-up and clean the machine regularly as
indicated in the maintenance instructions.
Carry out a visual check of the load for cleanliness.
The on-site shutoff valve must be easily accessible so that the water supply can be
turned off when not in use.
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PRODUCT INFORMATION
2.6 Training
Instructions for use of the machine will be provided by Miele Service or an authorized service
technician during machine commissioning.
It is the duty of the operator to ensure that users are sufficiently trained and instructed.
User profiles
The user profiles are identified as follows:
SERVICE Service technician
The machine may only be installed, commissioned, repaired, and maintained
by Miele Service or an authorized service technician.
ADMIN Responsible for the machine in the workplace:
More advanced tasks, e.g. interrupting or cancelling a program, require more
detailed knowledge of machine reprocessing of medical devices.
Alterations or adaptations of the machine, e.g. to accessories used or on-site
conditions, require additional specific knowledge of the machine.
Validation processes assume specialized knowledge about machine
reprocessing of medical devices, the processes involved, and applicable
standards and legislation.
USER User:
Users must be instructed in operating and loading the machine and trained
regularly to guarantee safe daily use.
They require knowledge of machine reprocessing of medical devices for dental
use.
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3. INSTALLATION
3.1 Water connection
Water quality
The quality of the water used in all the cleaning stages is essential in achieving good results.
The water must be compatible with the material from which the machine is made.
The water must be compatible with process chemicals.
The water must be compatible with process requirements for the various stages of the
process.
In order to achieve good cleaning results, the machine requires a supply of soft water with a
low calcium content. Hard water results in the build-up of calcium deposits on the load and
on the inner walls of the wash chamber.
Water with a hardness level higher than 0.7 mmol/l (4 gr/gal) must be softened. This occurs
automatically during a program sequence on machines with a built-in water softener. The
water softener must be set to the exact hardness of the water.
The water softener must be reactivated at regular intervals. This requires the use of special
reactivation salt. Reactivation is carried out automatically during a program sequence.
INSTALLATION
Note: The water hardness is set by Miele Service.
WARNING
Water from the chamber is not suitable for drinking!
The machine must be connected to the water supply in strict accordance with local
regulations.
The water used must at least comply with national regulations for drinking water quality. If the
water supply has a high iron content, there is a danger of corrosion occurring on the load and
the machine itself. If the chloride content of the water exceeds 100 mg/l, the risk of corrosion
to the load in the machine will be further increased.
A backflow preventer is not required if national regulations permit; the machine is equipped
with a safety system for the protection ofdrinking water.
The machine is installed as standard with connections for cold and DI water. Connect the
inlet hoses to the shutoff valves for cold and DI water.
The minimum flow pressure is 100 kPa at the cold water connection and 30 kPa at the DI
water connection.
The recommended flow pressure is ≥ 200 kPa for the cold water connection and ≥ 200 kPa
for the DI water connection in order to avoid excessively long water intake times.
The maximum permissible static water pressure is 800 kPa.
If water pressure is not within the specified range, contact Miele Service for advice.
A booster pump is required if the flow pressure is below 200 kPa. If the pressure is higher
than 800 kPa, a pressure reducer must be installed.
A shutoff valve with a ¾” threaded union must be provided on-site. The valve must be easily
accessible to allow the inlet to be turned off when not in use.
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INSTALLATION
WARNING
Do not overtighten the threaded unions on the hoses.
WARNING
When the machine is not in operation for long periods, always close the
shutoff valves.
Connecting the drain hose
Carefully check the drain hose.
Only use drain hoses resistant to organic and chemical materials and hot liquids (max.
91°C).
The diameter of the drain hose is listed in the installation plan.
The drain hose must not be extended.
The drain hose must be connected using a clamp.
The drain hose must not be kinked.
Wall drain: The drain point in the wall should be no higher than the machine drain
connection.
CAUTION
If the drain pipe is blocked, avoid skin and eye contact with potentially
contaminated water.
Wear suitable goggles and protective gloves.
CAUTION
Drainage must comply to national regulations.
The manufacturer cannot be held responsible if the incorrect use of
machine causes pollution.
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3.2 Electrical connection
WARNING
Only qualified, skilled personnel may connect the machine to the
domestic electrical supply.
The machine must only be operated with the voltage, frequency, and fuse rating
shown on the data plate.
Check that the power supply voltage does not differ from its nominal value by +/-6%.
The frequency of the power supply must not differ from its nominal value by more than
1%.
The electrical safety of the machine can only be guaranteed when correctly grounded.
Equipotential bonding is required.
Make sure that the electrical systems are properly grounded.
The ground conductor is to be connected to the ground terminal
identified by the standard symbol.
If the machine is hard wired to the power supply, connection
should be made via a power switch with all-pole isolation. The
power switch must be designed to operate at the rated current.
For increased safety, it is recommended to protect the machine with a suitable
residual current device (RCD) with a trip current of 30 mA.
The machine should be disconnected from the power supply when not used for a
longer period of time.
The electrical connection and fuse rating must comply with local and national
regulations.
The connection to the power supply must comply with national regulations, plug and
socket must be accessible for service and maintenance work after the machine has
been installed. An electrical safety test must be carried out after installation and after
any servicing work.
INSTALLATION
WARNING
Please refer to the installation plan provided.
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INSTALLATION
3.3 Installation site ventilation
During operation, the machine releases heat to its surroundings and increases humidity levels
at the place of installation. This applies particularly during drying.
These machines are equipped to be connected to an on-site exhaust air system.
WARNING
The machine should not be obstructed to guarantee proper ventilation.
In order to reduce the risk of water damage, the area around the machine
should be limited to furniture and fittings that are designed for use in
commercial environments.
Please refer to the installation plan provided.
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