Smeg WD5090TR36 User manual [GB]

WD5090
WD5090
WASHER DISINFECTOR
WD5090
USER MANUAL
2
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 ........................................................ 7
3.2 STANDARD 15883 .............................................................................................................................................. 7
4 MODELS ..................................................................................................................................................................... 8
4.1 WD5090 models ................................................................................................................................................ 9
4.1.1 50Hz Models ................................................................................................................................................. 9
4.1.2 60Hz Models ............................................................................................................................................... 10
5 GENERAL WARNINGS ............................................................................................................................................... 11
5.1 ACCESSING AND REUSING THE DEVICE AFTER AN INCOMPLETE CYCLE ......................................................... 12
6 GENERAL OPERATING INSTRUCTIONS .................................................................................................................... 13
6.1 POWERING ...................................................................................................................................................... 13
6.2 CONTROLS ....................................................................................................................................................... 13
7 FUNCTIONING .......................................................................................................................................................... 14
7.1 HOW TO OPEN THE WASHING CHAMBER DOOR .......................................................................................... 14
7.1.1 MANUAL DOOR RELEASE PROCEDURE ....................................................................................................... 15
7.2 SIDE CABINET DOOR OPENING - only if present ............................................................................................. 15
7.3 HOW TO CONDUCT A WASHING/DISINFECTING CYCLE .................................................................................. 16
7.4 HALTING A PROGRAM IN PROGRESS ............................................................................................................. 17
7.5 PERFORMING A STAND-ALONE DRYING CYCLE ............................................................................................. 17
7.6 PRINTING OUT THE LAST CYCLE PERFORMED................................................................................................ 18
7.7 POSTPONING THE CYCLE START ..................................................................................................................... 18
7.8 SECURITY POLICY, USER AND SUPER USER PASSWORDS ................................................................................ 18
8 COMMISSIONING INSTRUCTIONS ............................................................................................................................ 20
8.1 USING THE WATER SOFTENER ........................................................................................................................ 20
8.2 USING DETERGENTS ........................................................................................................................................ 20
8.2.1 LIQUID DETERGENT INTAKE SYSTEM .......................................................................................................... 20
8.2.2 GENERAL PRECAUTIONS FOR DETERGENTS ................................................................................................ 21
8.3 HOW TO REGULATE THE WASHING PRESSURE IN THE SPRAYING ARMS ....................................................... 22
1 DETERGENTS ............................................................................................................................................................ 23
9 LOAD PREPARATION ................................................................................................................................................ 24
10 WASHING PROGRAMS - DESCRIPTION ..................................................................................................................... 25
10.1 WASHING AND DISINFECTING PROGRAMS FOR OPERATING THEATERS ........................................................ 25
10.2 A0 PARAMETER – THERMAL DISINFECTIONS .................................................................................................. 26
11 ABBREVIATIONS LEGEND ......................................................................................................................................... 27
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12 ALARMS MESSAGES ................................................................................................................................................. 28
13 CLEANING AND MAINTENANCE ............................................................................................................................... 33
13.1 CLEANING THE DEVICE AND ITS PARTS ........................................................................................................... 33
13.2 DRYING AIR FILTER - only if present ................................................................................................................ 35
13.3 IF THE DEVICE IS TO BE OUT OF USE ............................................................................................................... 35
13.4 REUSING THE DEVICE AFTER A PERIOD OUT OF USE ...................................................................................... 35
13.5 TROUBLESHOOTING ........................................................................................................................................ 36
14 ROUTINE INSPECTIONS AND MAINTENANCE........................................................................................................... 37
14.1 DAILY ............................................................................................................................................................... 37
14.2 WEEKLY............................................................................................................................................................ 37
14.3 EVERY SIX MONTHS ......................................................................................................................................... 37
14.4 EVERY YEAR ..................................................................................................................................................... 37
15 INSTALLED MACHINE SET-UP ................................................................................................................................... 38
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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 61010­1:2010).
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 IEC61010-2-040:2015.
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 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. Note: the treatment in an Instrument
Washer is no substitute for sterilisation. Disinfection in an instrument washer is intended to reduce the risks for the staff who handle instruments and to prepare them for subsequent treatments and uses.
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 IEC61010-2-040:2015
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 IEC61010-2-040:2015.
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3.1 DEFINTITION: “RESPONSIBLE AUTHORITY” IN RELATION TO THE DEVICE
Responsible authority/body: individual or group responsible for the safe use and maintenance of equipment”. Definition taken from point 3.5.12 of the IEC61010-1:2010 standard.
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 MODELS
SYMBOL
MEANING
feature present
optional accessory, installable on the model in question
-
feature not present and not installable on the model in question.
Notes on variants - Power supply:
Unless otherwise specified, the device is set for a power supply of three-phase plus neutral (3N~) – this can be changed to single-phase on the user's premises by authorised technical staff. This configuration is also referred to as "standard" (STD).
If a specific power supply is indicated (e.g. "230V three phase without neutral", or "230V single­phase"), this means that the variant is preset for a specific type of power supply, which cannot be modified on the user's premises.
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4.1 WD5090 models
WD5090: instrument washers, 90cm, equipped with forced air drying system and side cabinet to take detergent cans.
4.1.1 50Hz Models
Id. code
860242
860243
860248
860564
Model
WD5090T
WD5090TFO
WD5090TR
WD5090TRFO
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
  
Panel printer
  
Mains frequency
50 Hz
50 Hz
50 Hz
50 Hz
Electrical connection
STD
STD
STD
STD
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4.1.2 60Hz Models
Id. code
860249
860250
860261
860469
860611
Model
WD5090T6
WD5090TF6
WD5090TR6
WD5090T36
WD5090TR36
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
Panel printer
Mains frequency
60 Hz
60 Hz
60 Hz
60 Hz
60 Hz
Electrical connection
STD
STD
STD
230 3~
230 3~
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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 IEC61010-2-040:2015).
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 IEC61010­2-040:2015).
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 IEC61010-2-040:2015.
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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