Miele PWD 8531, PWD 8532, PWD 8532 WS Operating instructions
Operating instructions
WASHER-DISINFECTOR
PWD 8531
PWD 8531 WS
PWD 8532
PWD 8532 WS
Read the operating instructions carefully before
installing and using the machine. This will help
protect users from personal injury and help
prevent damage to the machine.
en – GB, AU, IE, NZ
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
Authorisation for service and user training ................................................................................... 8
2.3
Safety instructions and warnings ................................................................................................. 9
Appropriate use ........................................................................................................................ 9
Risk 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 proper operation .................................................................................... 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
PWD 8531 and PWD 8531 WS ............................................................................................... 24
PWD 8532 and PWD 8532 WS ............................................................................................... 25
Warnings ................................................................................................................................. 26
6.OPERATION ........................................................................................................................................ 27
6.1
Checking consumption ............................................................................................................... 27
6.2
Opening and closing the door .................................................................................................... 28
Opening the door using the emergency release device ......................................................... 29
6.3
Switching on and off ................................................................................................................... 29
6.4
Preparation ................................................................................................................................. 30
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Contents
Preparing the load .................................................................................................................. 30
Preparing the machine ........................................................................................................... 32
Checks after a programme ..................................................................................................... 33
7.CONTROL PANEL AND SYMBOLS USED ......................................................................................... 34
7.1
Control panel .............................................................................................................................. 34
7.2
Buttons ....................................................................................................................................... 35
Buzzer ..................................................................................................................................... 35
7.3
Display ........................................................................................................................................ 36
8.PROGRAMMES ................................................................................................................................... 39
8.1
Starting the programme ............................................................................................................. 39
8.2
Programme structure .................................................................................................................. 40
8.3
Programme sequence ................................................................................................................ 41
9.MACHINE STATUS ............................................................................................................................. 42
9.1
Ready for operation .................................................................................................................... 42
9.2
Programme ................................................................................................................................. 42
9.3
Error messages ........................................................................................................................... 42
9.4
Power failure ............................................................................................................................... 43
9.5
Reset after error messages ........................................................................................................ 43
10.MENU ............................................................................................................................................. 44
10.1Entering the password ................................................................................................................ 44
10.2Setting the buzzer volume .......................................................................................................... 45
10.3Setting the date and time ........................................................................................................... 45
10.4Historical data output ................................................................................................................. 46
10.5Selecting a language .................................................................................................................. 47
10.6Changing user names ................................................................................................................. 48
10.7Parameter overview .................................................................................................................... 49
11.HISTORICAL DATA ......................................................................................................................... 50
11.1Outputting cycle reports retrospectively .................................................................................... 50
11.2External software ........................................................................................................................ 50
12.MESSAGES AND WARNINGS ....................................................................................................... 51
12.1Warning list ................................................................................................................................. 51
12.2Message list ................................................................................................................................ 52
13.PROCESS DOCUMENTATION ....................................................................................................... 53
13.1Serial interface ............................................................................................................................ 53
13.2User administration..................................................................................................................... 53
13.3USB port ..................................................................................................................................... 53
14.MAINTENANCE .............................................................................................................................. 54
14.1General recommendations on maintenance .............................................................................. 54
14.2Maintenance reminder ................................................................................................................ 54
14.3Routine maintenance .................................................................................................................. 54
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Contents
14.4Table of routine maintenance tasks ........................................................................................... 54
14.5Special maintenance .................................................................................................................. 59
Table of special maintenance work ...................................................................................... 59
15.PROBLEM – CAUSE – REMEDY .................................................................................................... 60
15.1Introduction................................................................................................................................. 60
15.2Problem (P) – Cause (C) – Remedy (R) ....................................................................................... 60
16.DISPOSING OF YOUR OLD MACHINE .......................................................................................... 61
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GENERAL RULES
1. GENERAL RULES
Further on in these operating instructions, the washer-disinfector is referred to simply as a
machine. Reprocessable medical devices are referred to as “items” if they are not defined in
more detail.
1.1 Limitation of liability
The manufacturer shall not be held liable for faults or problems which arise due to tampering
or 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 consider the intended use of the machine
Always carry out the required maintenance work
Use of the machine should be limited to persons who have been properly trained and
instructed on the use of the machine
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 machine and 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 this instruction manual with the machine for future reference.
If the machine is sold or transferred, the manual 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.
Read the warnings carefully before installing and using the machine.
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2. PRODUCT INFORMATION
Compliance with safety standards allows the user to work 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.
PRODUCT INFORMATION
PWD 8531
PWD 8531 WS
PWD 8532
PWD 8532 WS
REV.0.01_COD.500224_A4 Page 7
PRODUCT INFORMATION
2.1 Intended use
This machine can be used to reprocess a wide range of reusable medical devices for dental
use. Follow all instructions issued by 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 extractors, transmission instruments, etc.,
which are designated as reprocessable by the manufacturer, can be reprocessed in this
machine.
Improper use of this machine is any use other than that for which the machine is intended.
CAUTION
Inappropriate use can lead to personal injury and damage to property.
Miele cannot be held liable for damage caused by improper or incorrect
use or operation of the machine.
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 products must be reprocessed in compliance with national and local standards.
Washer-disinfectors are part of the process for reprocessing reusable medical devices.
2.2 Authorisation for service and user training
Miele & Cie. KG (hereinafter referred to as Miele) has been authorised by Steelco S.p.A, the
original equipment manufacturer, to provide technical training and user training for this
machine.
If reference is made to Miele Service or an authorised service agent, this is authorised by
Steelco S.p.A as the manufacturer.
The machine may only be installed, commissioned, repaired and maintained by Miele Service
or an authorised 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 help protect
users from personal injury and help prevent damage to the machine.
Keep these operating instructions in a safe place.
Appropriate use
Use of the machine is only permitted for the applications expressly approved in the
operating instructions. Alterations or conversion of the machine, or using it for purposes
other than those for which it was intended, are not permitted and could be dangerous.
The cleaning and disinfection processes are only designed for medical devices which are
designated reprocessable by the manufacturer. Instructions issued by load and
instrument manufacturers must be heeded.
Miele cannot be held liable for damage caused by improper or incorrect use or operation
of the machine.
This machine is intended for indoor use only.
Risk 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 authorised service technician. A Miele service contract is recommended to
ensure full compliance with medical device regulations (such as the German Medical
Device Ordinance). 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.
With some metal parts, there is a risk that you may be injured or cut. Wear cut-resistant
protective gloves when transporting and setting up the machine.
If the machine is installed under a worktop, it must only be installed under a continuous
worktop which is firmly secured to adjacent units to improve stability.
The electrical safety of the machine can only be guaranteed when it is correctly earthed.
It is essential that this basic 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 earthing 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 must 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.
Take care when using 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.
PRODUCT INFORMATION
REV.0.01_COD.500224_A4 Page 9
PRODUCT INFORMATION
The machine is only designed for use with water and appropriate 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.
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. Deactivating
the lock to open the door can result in a risk of burns and scalding.
Should personnel accidentally come into contact with toxic vapours or chemical agents,
follow the emergency instructions given in the manufacturer's safety data sheets.
Load carriers and the load should be allowed to cool down before removal. Any water
remaining in containers could still be very hot. Empty this water into the wash chamber
before removing items.
Never clean the machine or near vicinity with a water hose or a pressure washer.
The washer-disinfector must be disconnected from the mains 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 authorised personnel may interrupt a programme in exceptional circumstances.
The standard of cleaning and disinfection in the programmes must be routinely confirmed
by the user. Process results must be inspected and documented on a regular basis.
For thermal disinfection, use temperatures and temperature holding times to achieve the
required infection prophylaxis in accordance with current health and safety regulations.
Only reprocess undamaged and suitable items. When washing plastic items, ensure that
they are thermally resistant. Nickel-plated items and items made of aluminium 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
introduced into the wash chamber.
Under certain circumstances, process chemicals may damage 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 chemical
agents in this machine, even if they are recommended for machine use by the care
product 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
chemical agents can create foam. Foam can have an adverse effect on the disinfection
and cleaning result.
Reprocessing should not result in foam being discharged from the 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, 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
REV.0.01_COD.500224_A4 Page 11
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
chemical agents.
Particles ≥ 0.8 mm are removed by the filters in the wash 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, such as chemical agents,
water quality, etc., are discussed with Miele.
Load carriers which hold the load must be used only as intended.
Lumened items must be thoroughly cleaned, internally and externally.
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 chamber.
Solvents with a flash point below 21 °C may only be present in traces.
Chloride solutions, particularly hydrochloric acid, must not be introduced into the
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 mobile units, baskets, modules and inserts. Using baskets and inserts
made by other manufacturers or making modifications to Miele accessories can result in
an unsatisfactory cleaning and disinfection result. Any resultant damage would not be
covered by the guarantee.
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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.
Warning signs
To inform operating personnel of their obligations and to warn of residual risks, the machine
is equipped with safety labels in accordance with the relevant legislation.
General warning signs
PRODUCT INFORMATION
Caution!
Danger of electric shock!
The evaluation of risks for the health and safety carried out on-site, as well as the evaluation
of residual risks, determine the safety equipment which the operator must provide for the
user.
Miele cannot be held liable for damage or injury caused by noncompliance with the safety
instructions and warnings.
Observe the operating
Caution!
instructions!
Caution!
Hot surfaces!
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PRODUCT INFORMATION
2.4 Technical data
PWD 8531 PWD 8531 WS PWD 8532 PWD 8532 WS
Width (mm) 570 (+ 75) 570 (+ 75) 560 560
Depth with closed door (mm) 575 575 577 577
Height (mm) 535 535 825 825
Total weight (kg) 55 55 67 67
Wash chamber dimensions:
- Width (mm)
- Depth (mm)
- Height (mm)
Voltage, rated load, fuse rating See data plate and installation plan
Average sound pressure level < 70 dB(A)
Protection rating (according to
IEC 60529)
Operation: Temperature range +5 to +40 °C
415
480
375
IP 21
Relative humidity range 20 to 90 % without condensation
Maximum altitude: 2000 m ASL
415
480
375
415
480
375
415
480
375
Storage and transportation
conditions
Overvoltage category
(according to IEC EN 60664)
CE mark Medical Device Directive 93/42/EEC, Class IIb
Manufacturer address Steelco S.p.A
-5 to +50 °C
20 % to 90 % without condensation
500 hPa to 1060 hPa
II
Via Balegante, 27
31039 Riese Pio X (TV), Italy
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PRODUCT INFORMATION
2.5 Recommendations for proper operation
The user must supervise the machine during operation.
Load carriers with injector connections must be connected to the water supply.
When the machine is running, do not interrupt the programme as this will jeopardise
the reprocessing result.
The standard of cleaning and disinfection in the programmes must be routinely
confirmed by the user. Process results must be inspected and documented on a
regular basis.
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 introduce items containing substances which must not be discharged into the
sewage system. These substances must be disposed of separately.
The machine is designed 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 result in premature wear on components.
Solvent residues, chloride solutions and acids, particularly hydrochloric acid, can
damage steel components and must not be introduced into the wash chamber.
Do not use powder cleaning agents.
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 stopcock must be easily accessible so that the inlet 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 authorised service
technician during machine commissioning.
It is the duty of the supervisor 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 authorised service technician.
ADMIN Responsible for the machine in the workplace:
More advanced tasks, e.g. interrupting or cancelling a programme, 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 specialist 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 in
the machine.
Mains water with a hardness level higher than 0.7 mmol/l (4 °dH – German scale) must be
softened. This occurs automatically during a programme sequence on machines with a builtin water softener. The water softener must be set to the exact hardness of the water supply.
The water softener must be reactivated at regular intervals. This requires the use of special
reactivation salt. Reactivation is carried out automatically during a programme sequence.
INSTALLATION
Note: The water hardness is set by Miele Service.
CAUTION
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 comply with European regulations for drinking water quality as a
minimum. If the water supply has a high iron content, there is a danger that corrosion may
occur on load items 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 non-return valve is installed inside the machine in accordance with the applicable European
standards.
The machine is fitted as standard with connections for cold and DI water. Connect inlet hoses
to the 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 for the cold water connection is ≥ 200 kPa and for DI
water ≥ 200 kPa 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 stopcock 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
CAUTION
Do not overtighten the threaded unions on the hoses.
CAUTION
When the machine is not in operation for long periods, always close the
stopcocks.
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 by 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.
ATTENTION
If the drain pipe is blocked, avoid skin and eye contact with potentially
contaminated water.
Use suitable glasses and gloves.
ATTENTION
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
CAUTION
Only qualified, skilled personnel may connect the machine to the mains
supply.
The machine must only be operated with the voltage, frequency and fuse rating shown
on the data plate.
The connection to the power supply should be via a suitably rated plug and socket.
Check that the power supply voltage does not differ from its nominal value by
+/- 10 % (+10%/-6% for the UK).
The frequency of the power supply voltage must not differ by more than 1 %.
The electrical safety of the machine can only be guaranteed when it is correctly
earthed. Equipotential bonding is required.
Make sure that the electrical systems are properly earthed.
The earth conductor must be connected to the earth terminal
identified by the standard symbol.
If the machine is hard-wired to the power supply, it must be
connected via a mains switch with all-pole isolation. The mains
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 (DIN VDE 0664).
The machine should be disconnected from the mains supply when not use 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
CAUTION
Please refer to the installation plan provided.
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INSTALLATION
3.3 Installation site ventilation
During operation, the machine releases energy to its environment 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 extraction system.
CAUTION
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.
REV.0.01_COD.500224_A4 Page 20
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