Smeg WD3060 User manual [GB]
WD3060
WD5090
WD3060 - WD5090
WASHER DISINFECTOR
- USER MANUAL -
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CONTENTS
1 READ THE USER MANUAL WITH CARE ....................................................................................................................... 4
2 KEY TO THE SYMBOLS USED IN THE MANUAL AND ON THE APPLIANCE ................................................................... 5
3 INTENDED USE ........................................................................................................................................................... 6
3.1 DEFINTITION: “RESPONSIBLE AUTHORITY” IN RELATION TO THE DEVICE ........................................................ 6
3.2 STANDARD 15883 .............................................................................................................................................. 7
4 WD – MODELS ............................................................................................................................................................ 8
5 GENERAL WARNINGS ................................................................................................................................................. 9
5.1 ACCESSING AND REUSING THE DEVICE AFTER AN INCOMPLETE CYCLE ......................................................... 10
6 GENERAL OPERATING INSTRUCTIONS .................................................................................................................... 11
6.1 POWERING ...................................................................................................................................................... 11
6.2 CONTROLS ....................................................................................................................................................... 11
7 FUNCTIONING .......................................................................................................................................................... 12
7.1 HOW TO OPEN THE WASHING CHAMBER DOOR .......................................................................................... 12
7.1.1 MANUAL DOOR RELEASE PROCEDURE ....................................................................................................... 13
7.2 SIDE CABINET DOOR OPENING - only if present ............................................................................................. 13
7.3 HOW TO CONDUCT A WASHING/DISINFECTING CYCLE .................................................................................. 14
7.4 HALTING A PROGRAM IN PROGRESS ............................................................................................................. 15
7.5 PERFORMING A STAND-ALONE DRYING CYCLE ............................................................................................. 15
7.6 PRINTING OUT THE LAST CYCLE PERFORMED................................................................................................ 16
7.7 POSTPONING THE CYCLE START ..................................................................................................................... 16
7.8 SECURITY POLICY, USER AND SUPER USER PASSWORDS ................................................................................ 16
8 COMMISSIONING INSTRUCTIONS ............................................................................................................................ 18
8.1 USING THE WATER SOFTENER ........................................................................................................................ 18
8.2 USING DETERGENTS ........................................................................................................................................ 18
8.2.1 LIQUID DETERGENT INTAKE SYSTEM .......................................................................................................... 18
8.2.2 GENERAL PRECAUTIONS FOR DETERGENTS ................................................................................................ 19
8.3 HOW TO REGULATE THE WASHING PRESSURE IN THE SPRAYING ARMS ....................................................... 20
9 LOAD PREPARATION ................................................................................................................................................ 21
10 WASHING PROGRAMS - DESCRIPTION ..................................................................................................................... 22
10.1 WASHING AND DISINFECTING PROGRAMS FOR OPERATING THEATERS ........................................................ 22
10.2 PARAMETRO DI TERMODISINFEZIONE A0 ....................................................................................................... 23
11 ABBREVIATIONS LEGEND ......................................................................................................................................... 24
12 ALARMS MESSAGES ................................................................................................................................................. 25
13 CLEANING AND MAINTENANCE ............................................................................................................................... 30
13.1 CLEANING THE DEVICE AND ITS PARTS ........................................................................................................... 30
13.2 DRYING AIR FILTER - only if present ................................................................................................................ 32
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13.3 IF THE DEVICE IS TO BE OUT OF USE ............................................................................................................... 32
13.4 REUSING THE DEVICE AFTER A PERIOD OUT OF USE ...................................................................................... 32
13.5 TROUBLESHOOTING ........................................................................................................................................ 33
14 ROUTINE INSPECTIONS AND MAINTENANCE........................................................................................................... 34
14.1 DAILY ............................................................................................................................................................... 34
14.2 WEEKLY............................................................................................................................................................ 34
14.3 EVERY SIX MONTHS ......................................................................................................................................... 34
14.4 EVERY YEAR ..................................................................................................................................................... 34
15 INSTALLED MACHINE SET-UP ................................................................................................................................... 35
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1 READ THE USER MANUAL WITH CARE
This manual is an integral part of the appliance.
Take good care of it and keep it to hand throughout the appliance’s life cycle.
This manual and all the information it contains must be read carefully before using the appliance.
Failure to read, misunderstanding or incorrect interpretation of the instructions provided in this manual may lead to
misuse of the appliance, put the operator at risk and considerably reduce the appliance’s performance.
Installation, maintenance and any repairs must be carried out by authorised technical staff.
Apart from leading to forfeiture of warranty cover, repairs performed by unauthorised staff may put the
user’s safety at risk.
Any components must always be replaced with genuine spare parts.
Use of the device in breach of the instructions provided by the manufacturer may jeopardise the specified
protection level (safety of the appliance) and the warranty cover for it (see point 5.4.4 of IEC 610101:2001).
The manufacturer declines all liability for uses other than those described in this manual.
Consumables (detergents, air filters, thermal printer paper, etc.) are not covered by the warranty, except
for any manufacturing defects.
The Warranty does not cover any parts found to be faulty due to negligent or careless use, improper use,
failure to comply with the appliance’s operating instructions, incorrect installation or maintenance,
maintenance or repairs performed using by unauthorised staff or repairs made with non-genuine parts,
damage during transport, or any circumstances in which the appliance’s defects cannot be traced back to
manufacturing faults. Any work relating to installation and connection to the intake and drain systems, and
the maintenance work described in the operator’s manuals, are also excluded from the Warranty.
Any accessories may not be installed on the appliance by the user; this must be done by authorised
technical staff.
To request technical documentation relating to accessories, contact the manufacturer.
The information in this manual is provided for guidance only. The contents and the equipment described may be
subject to change without notice.
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2 KEY TO THE SYMBOLS USED IN THE MANUAL AND ON THE APPLIANCE
The following is the key to the symbols used on the appliance and in this manual, as required by point 5.4.4.e of
IEC61010-2-040:2005.
Read with particular attention.
(Symbol which appears beside particularly important instructions or warnings).
Warning, danger: refer to the manual.
(The symbol appears on the appliance’s technical dataplate to emphasise that staff must read the
manual before using the device.
The symbol appears in the manual next to safety instructions)
Warning, hot surface.
(the symbol is affixed to the appliance close to parts which may heat to high temperatures and
constitute a burn hazard - do not touch parts near this symbol. The symbol appears in the manual to
emphasise safety instructions relating to the burn hazard).
Warning, electric shock hazard.
(The symbol is affixed close to live parts - the device’s power supply must be disconnected before doing
any work on these parts. Never touch live parts unless the electricity supply is disconnected).
Transport and unpacking precautions.
Biohazard.
Flammability hazard.
At the end of its working life, the product must be consigned to a disposal plant for recovery and
recycling in accordance with the relevant legislation in the country of installation. Contact the specialist
disposal consortia.
At the end of its lifetime the appliance may be contaminated, especially the chamber and water circuit
(e.g. if the appliance has ended its working life due to a fault that has caused the failure of the last
thermal disinfection cycle): take appropriate care when decommissioning.
THIS APPLIANCE IS MARKED ACCORDING TO THE EUROPEAN DIRECTIVE 2002/96/EC ON WASTE
ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE). BY ENSURING THIS PRODUCT IS DISPOSED OF
CORRECTLY, YOU WILL HELP PREVENT POTENTIAL NEGATIVE CONSEQUENCES FOR THE
ENVIRONMENT AND HUMAN HEALTH, WHICH COULD OTHERWISE BE CAUSED BY INAPPROPRIATE
WASTE HANDLING OF THIS PRODUCT.
CE marking, notified body IMQ.
This symbol appears on the appliance’s technical data label and in this manual, indicating that it is a
medical device which holds EC CERTIFICATION issued by IMQ (“0015” is the code number of the notified
body IMQ).
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3 INTENDED USE
Instrument washers for use in hospitals, class IIb medical devices (in accordance with the classification criteria
established by Directive 93/42 and subsequent additions and amendments, extended and amended by EC Directive
2007/47).
INTENDED USE: treatment, through washing and thermal disinfection, of instruments inside hospitals and dental
centers to prevent, thanks to thermal disinfection, the spread of infectious agents that could potentially harm dental
personnel and final patients.
This product is designed exclusively for the applications described in the manual, especially for CSSD (Central
Sterilisation Supply Departments), substerilisation, hospitals, clinics and laboratories. Any other use is considered
improper use.
The appliance is built to provide the following function:
Washing with Thermal Disinfection of surgical or dental instruments;
The appliance cannot be used to sterilize instruments or any other device.
The type of instrument which can be processed in a cycle depends on the washing trolley used.
The device is supplied as standard without washing trolleys; contact the manufacturer for advice about the trolleys
best suited to your needs.
Any use other than that described in this manual constitutes misuse.
The manufacturer declines all liability for uses other than those stated above.
The manufacturer declines all liability for any damage caused by the use of the appliance to wash
glassware or instruments not approved by their manufacturers for automatic decontamination by means of
thermal disinfection.
The appliance may only be used by specifically trained staff. The authorized installation engineer will
train the staff assigned to use the appliance at the time of installation.
The manufacturer declines all liability in the event of malfunctions or accidents caused by use of the
appliance by untrained staff.
The training of the staff responsible includes specific information on the possible risks involved in the use
of the appliance, and training in the safest possible way of carrying out the operating procedures.
The installation engineer is also responsible for notifying the responsible authority of the USER and
SUPERUSER passwords for access to the setup parameters. The responsible authority must keep these
passwords in a safe place.
It is the duty of the appliance’s RESPONSIBLE AUTHORITY to ensure that those using the equipment have
been suitably trained in its operation, its safe use and routine checks, and that this training is suitably
maintained.
Staff training should be checked regularly.
The installation engineer is responsible for ensuring that it operates correctly after commissioning.
Safety information supplied in compliance with 5.4.101.1 IEC61010-2-040:2005
Instrument manufacturers’ instructions should always be followed when choosing the most appropriate
disinfection treatment.
In particular, it is important to check the compatibility of the load for treatment with the specific washing
cycle chosen, in terms of the maximum temperatures reached and the chemicals used.
Information supplied in compliance with point 5.4.4.r IEC61010-2-040:2005.
3.1 DEFINTITION: “RESPONSIBLE AUTHORITY” IN RELATION TO THE DEVICE
Responsible authority: “Person or group responsible for the use and ordinary maintenance of the unit and for operator
training.” Definition taken from point 3.5.13 of the IEC61010-1:2001 standard.
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The responsible authority should be clearly identified within the facility where the appliance is used, (for example by
recording the relative names and responsibilities on corporate forms).
3.2 STANDARD 15883
The standard of reference for the performance of a thermal disinfection appliance is EN ISO 15883.
With reference to the point 6 of 15883-1: as well as the compliance of the device “as supplied”, in charge of the manufacturer, the
standard requires to undertake further checks relating to the device “as installed”, in a sequence of processes known as “validation”. The
validation process is in charge of the Responsible authority for the device.
VALIDATION
The validation process for a thermal disinfection device under EN ISO 15883-1 involves 3 different phases.
1. Installation Qualification - IQ
2. Operational Qualification - OQ
3. Performance Qualification - PQ
installation qualification - IQ
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification
operational qualification - OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance
with its operational procedures
performance qualification - PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational
procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification
Note on performance qualification
Performance qualification must be carried out after completion of installation and operational qualification.
Performance qualification must be carried out whenever new or modified objects are placed in the appliance for washing and
disinfection, or new load systems are used, unless proof is provided that they are equivalent to an approved reference load or an object
or load system already approved in the past.
Performance qualification must be carried out when new process parameters (including process chemicals) are adopted.
Operational qualification should be repeated at set intervals to provide regular verification of the appliance’s operation.
Repetition of performance qualification for each appliance every year is suggested.
WARNING - USE OF PROBES FOR VALIDATION
The basic appliance does not feature a physical port as envisaged by the EN ISO 15883 standard for the insertion of probes with cable:
the use of wireless probes (dataloggers or similar) is recommended.
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4 WD – MODELS
Model
Differences between models
WD3060
instrument washers, 60cm, without drying system.
WD5090
instrument washers, 90cm, with forced-air drying system and side cabinet to take detergent cans.
Standard configuration of the product
Model
WD3060
WD5090
Variant / Features
860140
860221
860222
860242
860248
860244
860243
860564
P1 - Peristaltic detergent
pump
P2 - Neutralising agent
peristaltic pump
P3 - Optional peristaltic
pump
P4 - Optional peristaltic
pump
P5 - Optional peristaltic
pump
- - -
Drying system
- - -
HEPA H13 absolute filter (air)
- - -
Steam condenser
P1 Detergent dispensing
monitoring
P2 Neutralising agent
dispensing monitoring
P3 pump dispensing
monitoring
P4 pump dispensing
monitoring
P5 pump dispensing
monitoring
Jerry can level monitoring P1
– SP1
Jerry can level monitoring P2
– SP2
Jerry can level monitoring P3
– SP3
Jerry can level monitoring P4
– SP4
Jerry can level monitoring P5
– SP5
- - -
Rails in chamber for upper
trolley
-
- - -
-
Side cabinet to take
detergent cans
- - -
Other / particular features
-
Single phase
230V
- - -
Panel printer
Panel printer
Panel printer
SYMBOL
MEANING
feature present
optional accessory, installable on the model in question
-
feature not present and not installable on the model in question.
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5 GENERAL WARNINGS
.Leaning or sitting on the open door of the device might cause it to tip over, putting people in danger.
The door is not designed primarily to support loads.
.The maximum weight which can be loaded on the door, including the weight of the instrument trolley,
must never exceed 37kg (if the weight of the instrument trolley and baskets is excluded, the maximum
processable load must never exceed 23kg).
.For optimal DRYING, the load for processing must never exceed 15 kg.
.With use of the device, localised or general discolouring of the heating element may occur. This is normal
since it is due to the operating mode and does not reduce the appliance’s effectiveness.
.In the event of malfunction, disconnect the appliance from the electricity supply and turn off the water
tap. Then contact your nearest authorised Service Centre.
.Open the door carefully, first waiting for the wash cycle to end. The appliance has an automatic door
opening system; do not force the door open while a program is in progress.
.The appliance must only be used by staff suitably trained in its operation.
.The chamber of the appliance is not designed for users to climb into it. The user must never climb into the
chamber; this might put his safety at risk (ref. 7.102 IEC61010-2-040:2005).
DEMI WATER ABSENCE
If demineralised water is not available, the user is responsible for ensuring that the quality of the water
supplied to the medical device does not cause mineral salts or other substances to be deposited on the
treated instruments, rendering their subsequent use unsafe.
Do not place flammable substances inside the device. Do not use flammable detergents.
Never place alcohol or solvents such as turpentine, which might cause an explosion, inside the appliance.
Do not place materials dirty with ash, wax or paint inside the appliance.
Never touch the heating element immediately after the end of a wash programme.
Do not touch any residual liquids left inside the washing chamber; scalding hazard (ref. 7.102.c IEC610102-040:2005).
When moving the appliance around, a forklift truck or pallet truck must be used.
Before leaving the factory, the base of the appliance is secured to a pallet, which is used for lifting and
transporting it.
Do not use appliances which have been damaged in transit!
If in doubt, contact your dealer.
Once decommissioned, the appliance must be rendered unusable. Cut the power supply cable after
removing the plug / disconnecting the cable from the power socket.
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5.1 ACCESSING AND REUSING THE DEVICE AFTER AN INCOMPLETE CYCLE
The instructions relating to the device’s safety in the event of an incomplete operating cycle are provided in
compliance with points 5.4.4.g and 13.1.102 of IEC61010-2-040:2005.
WARNING
If a disinfection cycle is interrupted (by the user or due to an alarm generated by the appliance itself): take
care when handling the instruments and the load in general in the washing chamber. The load and the
internal parts of the appliance might be biologically contaminated/infected.
Before handling tools or performing any maintenance: Perform a complete disinfection cycle or, if you
cannot perform a complete Thermo-disinfection cycle, handle tools with caution (using protection devices
required for the handling of infected instruments, eg. gloves, lab coat).
DANGER, HOT SURFACES
The appliance performs a thermal disinfection cycle using water at high temperatures (up to 93°C) and
detergents. If, in the event of a failure, there is water in the chamber when the door is open: avoid contact
with the skin, burning hazard and risk of irritation due to the toxicity of the chemicals used.
Never touch the heating elements inside the chamber.
Contact Smeg authorised technical staff in the event of a failure.
Fig. 1- View of inside of chamber, detail of heating elements.
Do not touch
the heating
elements
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6 GENERAL OPERATING INSTRUCTIONS
6.1 POWERING
60 cm MODELS. main switch.
90 cm MODELS. The main switch “S1”, that powers on the device, is located in the cabinet at the side and can only be
accessed after the door of the side compartment has been opened. The door of the side cabinet can be open simply
pulling its handle.
6.2 CONTROLS
The keyboard is divided into two separate sections:
. The left-hand part of the display with keys for starting and stopping a program, and for the reset process;
. The right-hand part of the display, which contains the keys used for selecting/editing programs, selecting the
machine parameters and the various functions/adjustments.
A complete list of the keys and their relative functions is given below.
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