Euronda E9 Next 18L User manual

Instructions manual
0051
E9 Next

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Dear Sir or Madam,
first of all we would like to thank you for purchasing our E9 NEXT steriliser.
Please feel free to contact us if you require any further information or have any queries concerning the
operation and use of this equipment.
We strongly recommend, however, that you first read this manual with care to ensure correct use of the
product. Our devices comply with all the applicable safety regulations in force and present no danger to the
operator when used according to the instructions. Please also note that Euronda S.p.A. declines all liability
for incorrect or insufficient interpretations of the translations of this manual: in the event of a dispute, only the
manual written in the Italian language shall apply.
While wishing you success in your work, we remind you that the reproduction of this manual is forbidden and
that the technical components may be changed without notice due to our ongoing technical research.
EURONDA S.p.A.

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CONTENTS
CHAPTER 1 ...................................................................................................................................................... 5
1.1 WARRANTY ................................................................................................................................5
CHAPTER 2 ...................................................................................................................................................... 6
2.1 REFERENCE STANDARDS .......................................................................................................6
2.2 STAFF REQUIREMENTS ...........................................................................................................6
2.3 USING AND STORING THE MANUAL.......................................................................................6
2.4 READING THE MANUAL: SYMBOLS AND CONVENTIONS ....................................................7
2.5 HOW TO OBTAIN A NEW COPY OF THE MANUAL .................................................................7
CHAPTER 3 ...................................................................................................................................................... 8
3.1 GENERAL SAFETY WARNINGS................................................................................................8
3.2 INTENDED USE ..........................................................................................................................9
3.3 SAFETY DEVICES......................................................................................................................9
3.4 RESIDUAL RISKS.....................................................................................................................11
3.5 SAFETY SIGNS ON THE UNIT ................................................................................................11
3.6 PERSONAL PROTECTIVE EQUIPMENT (PPE)......................................................................11
CHAPTER 4 .................................................................................................................................................... 12
4.1 WEIGHT AND DIMENSIONS OF PACKAGING .......................................................................12
4.2 RECEIPT AND HANDLING.......................................................................................................12
4.3 DESCRIPTION OF CONTENTS ...............................................................................................12
4.3.1 Optional devices (also see Appendix 10) ..................................................................................12
CHAPTER 5 .................................................................................................................................................... 13
5.1 DESCRIPTION OF UNIT...........................................................................................................13
5.1.1 Front elements...........................................................................................................................13
5.1.2 Rear elements ...........................................................................................................................13
5.1.3 Upper elements .........................................................................................................................14
5.2 OVERALL SPACE REQUIRED.................................................................................................15
5.3 TECHNICAL DATA AND NOISE...............................................................................................16
5.3.1 Rating plate................................................................................................................................17
5.3.2 Noise level .................................................................................................................................18
5.4 OPTIONAL PRINTER (INTEGRATED OR EXTERNAL) ..........................................................18
5.4.1 Integrated label printer...............................................................................................................18
CHAPTER 6 .................................................................................................................................................... 20
6.1 WORK ENVIRONMENT: POSITIONING ..................................................................................20
6.2 INSTALLING THE UNIT ............................................................................................................21
6.3 ELECTRICAL CONNECTIONS.................................................................................................22
6.4 FIRST START-UP .....................................................................................................................23
6.5 HOW TO USE THE CONTROL PANEL....................................................................................23
6.5.1 How to use the control panel .....................................................................................................23
6.6 INSTALLATION MENU .............................................................................................................24
6.7 TANKS: INSTRUCTIONS FOR FILLING AND DRAINING .......................................................24
CHAPTER 7 .................................................................................................................................................... 28
7.1 PROGRAM MENU ....................................................................................................................28
7.2 SELECTING A STERILIZATION CYCLE..................................................................................30
7.2.1 Start-up, execution and end of a cycle ......................................................................................31
7.2.2 Information on process parameters...........................................................................................33
7.2.3 How to unlock the Personal cycles............................................................................................34

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7.3 SELECTING A TEST.................................................................................................................35
7.3.1 Start-up, execution and end of a test ........................................................................................36
7.4 MANUALLY STOPPING A CYCLE OR A TEST .......................................................................37
7.4.1 Manually stopping a cycle before or during the sterilization phase...........................................37
7.4.2 Manually stopping a cycle after the sterilization phase .............................................................38
7.5 POWER BLACKOUTS ..............................................................................................................38
7.6 RESETTING THE UNIT AFTER AN INTERRUPTION CAUSED BY AN ALARM....................38
7.7 SETTINGS.................................................................................................................................38
7.7.1 Date and time set up .................................................................................................................39
7.7.2 Expiry days and label number set up ........................................................................................39
7.7.3 User set up ................................................................................................................................39
7.7.4 Printer and printer type set up ...................................................................................................42
7.7.5 Label reprinting management ............................................................................................................ 43
7.7.6 Language set up........................................................................................................................43
7.7.7 Aquafilter setup..........................................................................................................................44
7.7.8 Release of the load through the identification of the user .........................................................45
7.7.9 Ethernet connection set up........................................................................................................46
7.7.10 Planning set up..........................................................................................................................47
7.9 LONG PERIODS OF INACTIVITY ............................................................................................49
CHAPTER 8 .................................................................................................................................................... 50
8.1 E-MEMORY SOFTWARE .........................................................................................................50
8.1.1 Minimum system requirements..................................................................................................50
8.1.2 Installing the E-Memory software ..............................................................................................50
8.1.3 User interface ............................................................................................................................51
8.1.4 General warnings ......................................................................................................................52
8.2 SOFTWARE CONFIGURATION...............................................................................................53
8.2.1 User management .....................................................................................................................53
8.3 INSERTING AND REMOVING THE SD CARD ........................................................................54
CHAPTER 9 .................................................................................................................................................... 56
9.1 SAFETY WARNINGS................................................................................................................56
9.2 ORDINARY MAINTENANCE ....................................................................................................56
9.2.1 Periodic maintenance ................................................................................................................60
9.2.2 Adjustment of the closing mechanism.......................................................................................61
9.3 EXTRAORDINARY MAINTENANCE ........................................................................................62
9.3.1 Rusting.......................................................................................................................................63
CHAPTER 10 .................................................................................................................................................. 64
10.1 INSTRUCTIONS FOR DISPOSAL............................................................................................64
10.2 RESALE.....................................................................................................................................64
APPENDIX 1 ................................................................................................................................................... 65
Preparing the instruments for sterilization..............................................................................................65
APPENDIX 2 ................................................................................................................................................... 66
Packaging...............................................................................................................................................66
APPENDIX 3 ................................................................................................................................................... 67
Positioning the load ................................................................................................................................67
APPENDIX 4 ................................................................................................................................................... 68
Unloading and preserving sterilized instruments ...................................................................................68

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APPENDIX 5 ................................................................................................................................................... 69
Description of programs .........................................................................................................................69
APPENDIX 6 ................................................................................................................................................... 71
Description of Tests................................................................................................................................71
APPENDIX 7 ................................................................................................................................................... 74
Validating the cycles...............................................................................................................................74
APPENDIX 8 ................................................................................................................................................... 75
Quality of process water .........................................................................................................................75
APPENDIX 9 ................................................................................................................................................... 76
Troubleshooting......................................................................................................................................76
APPENDIX 10 ................................................................................................................................................. 83
Description of optional devices...............................................................................................................83

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CHAPTER 1
1.1 WARRANTY
Euronda guarantees the quality of its equipment, if used in accordance with the instructions supplied in this
manual, and according to the conditions printed on the warranty certificate.
The warranty is valid from the date of purchase by the client and the details can be found by registering on
www.euronda.com/myeuronda
In the case of dispute, the date indicated on the purchase invoice, showing the serial number of the unit, will
be considered as valid.
NOTE 1: please retain the original packaging and use it each time the unit needs to be transported. The use
of different packaging could damage the product during transportation.
NOTE 2: in order to release the Personal Functions, the user must complete the registration at the
www.euronda.com/myeuronda portal, where an information document can be found, required to take
advantage of the Light and Light & Stock cycles (for further specifications refer to page 16 of the above
Manual).

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CHAPTER 2
2.1 REFERENCE STANDARDS
Steam sterilizer E9 NEXT.
The saturated steam sterilizer complies with the essential requirements of Council Directives:
Medical devices 93/42/EEC of 14/06/93 and 2007/47/EC, class IIb - 0051
It also complies with the national standards in their harmonized versions:
EN 13060
EN 61010-2-040
EN 61326
Boiler
The boiler complies with the following standards:
EN 13445
It also complies with the essential requirements of Council Directives:
Pressure vessels 2014/68/UE del 15/05/2014 - Category II–D1 - 0497
2.2 STAFF REQUIREMENTS
The staff authorized to use and service the equipment must possess the following requirements:
- sufficient general culture to understand the contents of this manual;
- knowledge of the unit and its place of installation;
- knowledge of health, accident prevention, and technical regulations.
The main figures who operate and service the unit are shown below.
The OPERATOR is the person who physically uses the unit for the purpose for which it has been designed.
The RESPONSIBLE AUTHORITY is the person or group responsible for the use and routine maintenance of
the unit and for operator training.
The responsible authority is legally responsible for the installation, operation and use of the unit.
2.3 USING AND STORING THE MANUAL
This manual refers to the following series and models of appliance:
Series
Model
E9 NEXT E9 NEXT 18L
E9 NEXT 24L
This manual is an integral part of the product and must be kept near the unit for quick and easy consultation.
The purpose of this manual is to give instructions on:
- correct installation;
- the safe and efficient use of the unit;
- routine maintenance.
The unit must be used according to the procedures contained in the manual and only for the purpose for
which it was designed. The occupational health and safety directives in force in the Country of destination of
the unit must be known and applied in the place of use.
The manual must be kept in a safe place, easily accessible to all personnel; it must also be handled with
care. It is forbidden to remove, rewrite, or modify the contents of this manual in any way.
The drawings and any other documents delivered with the unit may not be divulged to third parties in that
Euronda S.p.A. is the sole owner and reserves all rights to them.
Reproduction of the text and illustrations, in full or in part, is strictly forbidden.

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Euronda S.p.A. reserves the right to make modifications or improvements to the manual or unit without
notice and without being obliged to update previous products and manuals. The information contained in this
manual refers to the unit the characteristics of which are specified in chap. 5.3.1 “Rating plate”.
If the unit is resold, it must be delivered to the new owner together with this manual. In this case, the maker
must be informed of the new owner (see chap. 11.2 “Resale”).
2.4 READING THE MANUAL: SYMBOLS AND CONVENTIONS
In this manual, symbols are placed beside certain descriptions, notes, etc..
These symbols are used to attract the attention of readers to a particular note or piece of information. Their
meanings are explained below.
SYMBOL
DESCRIPTION
IMPORTANT SAFETY INFORMATION
This symbol is used to draw the reader's attention to particularly important notions
for operator safety.
INFORMATION AND PRECAUTIONS
This symbol refers to general indications and advice.
STRICTLY FORBIDDEN
This symbol means it is strictly forbidden to perform the operation in question.
Failure to observe this prohibition may cause serious harm to the operator or
damage to the unit.
The manual is divided into chapters and sub-chapters; the figures are numbered with the chapter to which
they refer, with the addition of a progressive number. E.g. Fig. 3.4-1 (figure No. 1 relative to chap. 3.4).
2.5 HOW TO OBTAIN A NEW COPY OF THE MANUAL
If the manual is lost or destroyed, ask Euronda S.p.A. for a new copy. Provide the following information:
- model and serial number of the unit;
- name and address where the manual should be sent.
Send your request to the following address:
EURONDA SPA
Via dell’Artigianato, 7
I - 36030 Montecchio Precalcino
Vicenza - Italy
Tel. [phone]
Fax [phone]
E-mail [email protected]

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CHAPTER 3
3.1 GENERAL SAFETY WARNINGS
Carefully read the safety information before using the unit. Non-observance could cause
accidents or damage to the machine.
- Before using the unit, operators must have perfectly understood the meanings and functions of all the
controls.
- Operators must be aware of and know how to apply the safety regulations governing the use of the unit.
- Operators must know and correctly interpret all indications contained in this manual and those applied to
the unit.
- Operators must not perform operations on their own initiative or operations that are not part of their job.
- The responsible authority must instruct and train the operator to use and service the unit safely; in
particular, it must ensure that the information contained in this documents are correctly understood.
Particular attention must be paid to the emergency procedure concerning pathogenic materials released
into the atmosphere. This must be written in a special guide stored near the unit.
- In the event of malfunctions or potentially dangerous situations, operators MUST immediately report the
situation to the responsible authority.
- It is strictly forbidden to use or neutralize the safety devices.
- Make sure the unit is powered at the correct voltage.
- Make sure the unit is earthed and conforms to the standards applicable in the country of installation.
- Never dismantle the unit.
- Do not remove the outer guard before disconnecting the power supply: the unit contains live parts, fans
and heaters that could activate without warning.
- The internal high voltages are dangerous.
- If it is not possible to disconnect the power supply, disconnect the mains supply. If this is distant or not
visible by the person carrying out the maintenance work, turn the switch to "OFF" and secure it with a
padlock or, alternatively, lock the electrical cabinet and keep the key; always make sure the voltage is
effectively absent.
- Keep the area around the unit clean and dry.
- Do not use solvents on plastic parts or labels.
- Do not remove the labels on the unit. If necessary, ask for new ones.
- Clean the unit with a damp cloth after checking that the power cord is not connected (remove any traces
of moisture before using the unit again).
- Do not pour water or any other liquids onto the unit that could cause short circuits or corrosion.
- Do not touch the unit with wet hands or if the unit is wet; always follow the precautions required for the
use of electrical equipment.
- The unit was not designed for use in the presence of gas or explosive vapours.
- Do not expose the unit to excessive mechanical stress such as impacts or strong vibrations.
- Do not lean over or stand in front of the door when opening it as there is a risk of scalding from escaping
steam (see chap. 3.4 “Residue risks”).
- The used water in the discharge tank, or the parts in contact with the material to sterilise may contain
contaminated residues; it is therefore advisable to use protective rubber gloves during draining and
handling, in order to prevent the risk of pathogenic contamination (see chap. 6.7 “Tanks: instructions
for filling and draining" and chap. 3.4 "Residual risks").
- Before transporting the machine, drain both water tanks. Use the supplied drain tube and follow the
instructions for draining (see chap. 6.7 “Tanks: instructions for filling and draining”).
- Before being sterilised, all the materials must be treated as required by current law.
- Do not try to open the door in case of blackout during a sterilization cycle (see 3.4 “Residual Risks”).

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3.2 INTENDED USE
EN NEXT water steam steriliser: unit designed and developed for the sterilisation of instruments
used in medical, dental, veterinary and podology surgeries, and tattoo shops, that can be sterilised
by steam between 121°C and 134°C.
The unit is designed for use by professional, qualified persons only. The unit must only be used for the
purpose it was designed for.
The manufacturer cannot be held responsible for any breakage, damage or malfunctioning
of the unit if the machine has not been used correctly, been used inappropriately or not
adequately maintained.
3.3 SAFETY DEVICES
Electrical safety
Description
Ef
fect
Double-pole thermal protection circuit breaker for
protection against short-circuit.
Disconnects main electrical power supply
Protection of the electronic card against short-circuit:
both the transformer and the entire low-voltage
circuit are self-protected.
Disconnects one or more low-voltage circuits
Thermal protection
Description
Effect
Thermal protection of the unit: if anomalous
overheating occurs, the unit turns off.
The unit cannot be switched on until the manually
resettable thermostat on the front panel is reset.
The vacuum pump is protected by a automatically
resettable thermostat.
Temporary cut-off to permit cooling
The vibration pump is protected by a thermal fuse. Interruption of electrical circuit, replace the thermal
fuse.
Manually resettable thermostat protecting the steam
generator
Interruption of power input to the steam generator
until the thermostat on the generator is reset.
Safety valve, complying with the PED 97/23/EC
standards, for protecting the unit from over-pressure
Discharge of steam and re-balancing of pressure to
safety values