MELAG Vacuclave 550 User manual

User Manual
Vacuclave® 550
Steam sterilizer
from software version 4.0.1
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with ENISO13485. This guarantees that all MELAG products are manufactured and tested in accordance
with strict quality criteria.
The MELAG management and team.
0197

Contents
Contents
1 General guidelines ...............................................................................................................................................................7
Symbols used ......................................................................................................................................................................7
Formatting rules...................................................................................................................................................................7
Disposal ...............................................................................................................................................................................7
2 Safety.....................................................................................................................................................................................8
3 Performance specifications ................................................................................................................................................9
Intended use ........................................................................................................................................................................9
Sterilization procedure .........................................................................................................................................................9
Type of the feed water supply..............................................................................................................................................9
Program runs .....................................................................................................................................................................10
Safety equipment...............................................................................................................................................................10
Performance characteristics of reprocessing programs ....................................................................................................11
4 Description of the device...................................................................................................................................................12
Scope of delivery ...............................................................................................................................................................12
Views of the device............................................................................................................................................................13
Symbols on the device.......................................................................................................................................................15
Service hatch .....................................................................................................................................................................16
Power switch......................................................................................................................................................................16
Colour touch display ..........................................................................................................................................................17
LED status bar ...................................................................................................................................................................18
Menu..................................................................................................................................................................................18
Program run.......................................................................................................................................................................19
Heat recovery ....................................................................................................................................................................19
Load mounts ......................................................................................................................................................................19
5 Installation requirements...................................................................................................................................................20
Installation location ............................................................................................................................................................20
Electromagnetic environments.....................................................................................................................................20
Space requirements...........................................................................................................................................................21
Mains connection...............................................................................................................................................................22
Water connection...............................................................................................................................................................23
System and network safety................................................................................................................................................23
Operating the device with memory media....................................................................................................................24
Operating the device in the local network (LAN)..........................................................................................................24
Network bandwidth / Quality of Service (QoS).............................................................................................................25
6 Setup and installation ........................................................................................................................................................26
Removing from the packaging ...........................................................................................................................................26
Connecting the power cable and removing accessories ...................................................................................................27
Installation examples .........................................................................................................................................................28
Example 1 - Automatic water supply and disposal with reverse osmosis unit MELAdem 47 (HD)..............................28
Example 2 - Automatic water supply and disposal with ion exchanger MELAdem53/53C (HD)................................30
Example 3 - Automatic water supply and disposal with ion exchanger MELAdem53/ 53C (EA) ...............................32
Example 4 - Use of the filling pump with external storage and wastewater container .................................................34

Contents
Connection to the wastewater ...........................................................................................................................................35
Direct connection to the wastewater ............................................................................................................................35
Aligning the device.............................................................................................................................................................36
Turning the device .............................................................................................................................................................36
Mounting the loading slide .................................................................................................................................................37
Checking the software version...........................................................................................................................................39
Checking water supply and disposal .................................................................................................................................39
Checking date and time .....................................................................................................................................................39
Display brightness and volume..........................................................................................................................................39
Test runs............................................................................................................................................................................39
Instructing the users ..........................................................................................................................................................39
Record of installation and setup ........................................................................................................................................39
Service connection ............................................................................................................................................................40
Service settings .................................................................................................................................................................40
7 First steps ...........................................................................................................................................................................41
Switching on the device .....................................................................................................................................................41
Opening and closing the door............................................................................................................................................41
Opening the door .........................................................................................................................................................41
Closing the door ...........................................................................................................................................................42
Manual door emergency-opening ................................................................................................................................42
Feed water supply .............................................................................................................................................................43
Using of a water treatment unit ....................................................................................................................................43
Using an external storage container ............................................................................................................................43
Using the feed water tank (emergency operation) .......................................................................................................44
Disposal of the wastewater................................................................................................................................................44
8 Important information for routine operation....................................................................................................................45
9 Sterilization .........................................................................................................................................................................46
Preparing the load .............................................................................................................................................................46
Reprocessing instruments............................................................................................................................................46
Reprocessing textiles ...................................................................................................................................................46
Loading the steam sterilizer...............................................................................................................................................47
Closed sterile containers..............................................................................................................................................47
Soft sterilization packaging ..........................................................................................................................................48
Multiple wrapping .........................................................................................................................................................48
Mixed loads ..................................................................................................................................................................48
Load quantities and versions .......................................................................................................................................49
Mounts and loading slide .............................................................................................................................................49
Selecting the program........................................................................................................................................................50
Program options ................................................................................................................................................................51
Starting the program ..........................................................................................................................................................52
Manual program abort .......................................................................................................................................................53
Ending the program prematurely .......................................................................................................................................54
Program is ended ..............................................................................................................................................................54
Approval process .........................................................................................................................................................55
Removing the sterile material ............................................................................................................................................55
Storing sterile material .......................................................................................................................................................56

Contents
10 Logging .............................................................................................................................................................................57
Batch documentation .........................................................................................................................................................57
Label printer.......................................................................................................................................................................57
Logs menu .........................................................................................................................................................................58
Log list ...............................................................................................................................................................................58
Log output options........................................................................................................................................................59
Output media .....................................................................................................................................................................60
Displaying logs on the computer ..................................................................................................................................61
11 Function checks ...............................................................................................................................................................62
Service programs...............................................................................................................................................................62
Vacuum test.......................................................................................................................................................................62
Bowie & Dick test...............................................................................................................................................................64
12 Settings .............................................................................................................................................................................65
General settings.................................................................................................................................................................65
Language .....................................................................................................................................................................65
Date and time...............................................................................................................................................................65
Display brightness........................................................................................................................................................66
Volume .........................................................................................................................................................................66
Energy-saving ..............................................................................................................................................................67
Water management......................................................................................................................................................67
Program options...........................................................................................................................................................68
Log output ....................................................................................................................................................................69
Label print ....................................................................................................................................................................69
Administrative settings.......................................................................................................................................................70
User administration ......................................................................................................................................................70
Logging on user role ....................................................................................................................................................71
Logging off a user role .................................................................................................................................................72
Authentication ..............................................................................................................................................................72
Batch approval .............................................................................................................................................................73
Administrator PIN .........................................................................................................................................................73
Software update ...........................................................................................................................................................74
Network ........................................................................................................................................................................74
13 Maintenance......................................................................................................................................................................75
Servicing intervals..............................................................................................................................................................75
Checking and oiling the door lock......................................................................................................................................75
Changing the dust filter......................................................................................................................................................76
Cleaning.............................................................................................................................................................................76
Sterilization chamber, door seal, mount, trays .............................................................................................................76
Housing parts ...............................................................................................................................................................77
Feed water tank ...........................................................................................................................................................77
Maintenance ......................................................................................................................................................................79

Contents
14 Pause times ......................................................................................................................................................................80
Duration of the operating pause ........................................................................................................................................80
Decommissioning ..............................................................................................................................................................80
Draining .............................................................................................................................................................................80
Transport ...........................................................................................................................................................................81
Symbols on the packaging ...........................................................................................................................................81
On-site transport ..........................................................................................................................................................81
Off-site transport ..........................................................................................................................................................81
Installing the carrying system.......................................................................................................................................82
15 Malfunctions .....................................................................................................................................................................83
Malfunction logs.................................................................................................................................................................83
Warning and malfunction messages..................................................................................................................................84
16 Technical data ..................................................................................................................................................................93
17 Accessories and spare parts ..........................................................................................................................................95
18 Technical tables ...............................................................................................................................................................97
Feed water quality .............................................................................................................................................................97
Nominal value tolerances ..................................................................................................................................................97
Precision and drift behaviour .............................................................................................................................................98
Sensors ........................................................................................................................................................................98
Measuring chains .........................................................................................................................................................99
After 1 year...................................................................................................................................................................99
After 5 years.................................................................................................................................................................99
Pressure-time chart .........................................................................................................................................................100
Empty chamber test.........................................................................................................................................................101
Glossary ...............................................................................................................................................................................102

1 General guidelines
7
1 General guidelines
Please read this user manual carefully before commissioning the device. The manual includes important safety
instructions. Make sure that you always have access to digital or printed version of the user manual.
Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG
download centre at www.melag.com.
Symbols used
Symbol Description
Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening in-
juries.
Draws your attention to a situation, which if not avoided, could result in damage to the instru-
ments, the practice fittings or the device.
Draws your attention to important information.
Indicates the section in the document that contains content relevant for the service techni-
cian.
Formatting rules
Example Explanation
Universal-
Program
Words or phrases appearing on the display of the device are marked as display text.
Prerequisites for the following handling instruction.
Refer to the glossary or another text section.
Information for safe handling.
Disposal
MELAG devices are synonymous with high quality and a long life-span. When you eventually need to decommission your
MELAG device, the required disposal of the device can take place with MELAG in Berlin. Simply contact your stockist.
Dispose of accessories and consumption media which you no longer require in the appropriate manner. Comply with all
relevant disposal specification in terms of possibly contaminated waste.
The packaging protects the device against transport damage. The packaging materials have been selected for their
environmentally-friendly disposability and can be recycled. Returning the packaging to the material flow reduces the
amount of waste and saves raw materials.
Dispose of spare parts that are no longer used, e.g. seals, properly.
MELAG draws the operator’s attention to the fact that they are responsible for deleting personal data on the device to be
disposed of.
MELAG draws the operator’s attention to the fact that they may be legally obliged (e.g. in Germany according to
ElektroG) to remove used batteries and accumulators non-destructively before handing over the device, provided they
are not enclosed in the device.

2 Safety
2 Safety
When operating the device, comply with the following safety instructions as well as those contained in sub-
sequent chapters. Use the device only for the purpose specified in these instructions. Failure to comply
with the safety instructions can result in injury and/or damage to the device.
Qualified personnel
nAs with the preceding instrument reprocessing, only }competent personnel should undertake sterilization using this
steam sterilizer.
nThe operator must ensure that the users are regularly trained in the operation and safe handling of the device.
Power cable and power plug
nOnly the power cable included in the scope of delivery may be connected to the device.
nThe power cable may not be replaced by a cable determined to be insufficient.
nComply with all legal requirements and locally-specified connection conditions.
nNever operate the device if the plug or power cable are damaged.
nThe power cable or plug should only be replaced by }authorised technicians.
nNever damage or alter the power plug or cable.
nNever bend or twist the power cable.
nNever unplug by pulling on the power cable. Always take a grip on the plug.
nNever place any heavy objects on the power cable.
nEnsure that the power cable does not become jammed in.
nNever lead the cable along a source of heat.
nNever fix the power cable with sharp objects.
nThe mains socket must be freely accessible after installation so that the device can be disconnected from the
electrical mains at any time if necessary by pulling the mains plug.
Normal operation
nThe door area as well as the cooler and safety valves at the rear of the device may become hot during operation and
remain hot for an extended period after switching off.
nThe sterile filter is no longer effective if it has become wet. Stop using the sterile filter and replace it.
nDo not replace the sterile filter during a program run.
Opening the housing
nNever open the device housing. Incorrect opening and repair can compromise electrical safety and pose a danger to
the user. The device may only be opened by an }authorised technician who must be a }qualified electrician.
Notification requirement in the event of serious accidents in the European Economic Area
nPlease note that all serious accidents which occur in connection with the medical device (e.g. death or serious
deterioration in the state of health of a patient) which were presumably caused by the device, must be reported to
the manufacturer (MELAG) and the relevant authority of the member state, in which the user and/or patient resides.
8

3 Performance specifications
9
3 Performance specifications
Intended use
The Vacuclave 550 steam sterilizer is mainly intended for use in the medical sector, e.g. in medical and dental practices.
The small steam sterilizer is designed according to }EN 13060. It uses the fractionated vacuum process to ensure
effective steam penetration of the load with saturated steam. It is suitable for }reprocessing instruments and materials
that may come into contact with blood or body fluids during treatment. The steam sterilizer is not intended for use on
patients or in patient care and is not intended for the sterilization of liquids. Typical groups of users are doctors, skilled
medical personnel and service technicians.
WARNING
Any attempt to sterilize liquids can result in a }delay in boiling. This can result in burns and damage to
the device.
nNever use this device to sterilize fluids. It is not licensed for the sterilization of fluids.
Sterilization procedure
The steam sterilizer sterilizes on the basis of the }fractionated vacuum procedure. This guarantees the complete and
effective wetting or penetration of the load with saturated steam.
The steam sterilizer uses double jacket technology to generate the sterilization steam, i.e. the steam sterilizer is fitted
with a separate steam generator combined with a double-walled sterilization chamber. After heating, steam is held
constantly available in the double jacket. This gives the walls of the sterilization chamber a defined temperature and
protects the chamber itself from overheating.
This especially effective procedure supports the quick }evacuation of the air from the sterilization chamber, the
sterilization packages and instrument cavities. This allows you to sterilize large quantities of instruments or textiles in a
very short time and achieve very good drying results.
Type of the feed water supply
The steam sterilzer works with a feed water one-way system. This means that it uses fresh }feed water (}demineralised
or }distilled water) for every sterilization procedure. The quality of the feed water is subject to permanent monitoring via
integrated }conductivity measurement. If combined with a proper preparation of the instruments, this serves largely to
prevent stain accretion on the instruments and soiling of the steam sterilizer.

3 Performance specifications
Program runs
A reprocessing program runs in three main phases: the air removal and heating up phase, the sterilization phase and the
drying phase. After program start, you can follow the program run on the display. It shows the chamber temperature and
pressure as well as the time until the end of drying.
Program phases of a standard reprocessing program
Program phase Description
1. Air removal and heating
up phase
Air removal
The air removal phase comprises the conditioning and the fractionating phase. Dur-
ing conditioning, steam is repeatedly injected into and removed from the }steriliza-
tion chamber. This generates over-pressure and the residual air is removed. Then,
during fractionation, the mixture of air and steam is evacuated from the sterilization
chamber and steam is injected. This method is also called the fractionated vacuum
method.
Heating
The continued steam injection into the sterilization chamber leads to an increase in
pressure and temperature which continues until the program-specific sterilization
parameters have been reached.
2. Sterilization phase Sterilizing
If the pressure and temperature correspond to the program-dependent nominal
values, the sterilization phase begins. The corresponding process parameters (pres-
sure and temperature) are held at sterilization level.
3. Drying phase Pressure release
The sterilization phase is followed by pressure release from the sterilization cham-
ber.
Drying
The sterile material is dried using a vacuum (vacuum drying).
Ventilation
Upon program end, the sterilization chamber is filled with sterile air via the sterile fil-
ter and adjusted to the ambient pressure.
Program phases of the vacuum test
Program phase Description
1. Evacuation phase The sterilization chamber is evacuated until the pressure for the vacuum test has
been reached.
2. Equilibration time An equilibration time of five minutes will follow.
3. Measurement time The measurement time amounts to ten minutes. The pressure increase within the
sterilization chamber is measured during the measurement time. The evacuation
pressure and the equilibration time or measurement time are shown on the display.
4. Ventilation The chamber is ventilated after the end of the measuring time.
5. Test end The display shows the test result, the batch number, the total number of batches
and the leakage rate.
Safety equipment
Internal process monitoring
A }process evaluation system is integrated in the electronics of the steam sterilizer. It compares the process parameters
(such as temperature, time and pressure) during a program run. It monitors the parameters in terms of their threshold
values during control and regulation and guarantees safe and successful sterilization. A monitoring system checks the
device components of the steam sterilizer for their functionality and their plausible interaction. If one or more parameters
exceeds pre-determined threshold values, the steam sterilizer issues warnings or malfunction messages and if
necessary, aborts the program. In the case of a program abort, follow the instructions on the display.
The steam sterilizer uses an electronic parameter control. This enables the steam sterilizer to optimise the total operating
time of a program in dependence on the load.
10

3 Performance specifications
11
Internal logic monitoring
The electronics of the steam sterilizer monitor the successful program run by means of two separate test processes.
When a program has been successfully completed, it is shown on the display as a successful program. In addition, the
status LED below the display illuminates green.
Door mechanism
The device checks the pressure in the sterilizer chamber at any time and prevents the door from being opened if an over-
pressure exists. The motor-driven automatic door locking mechanism opens the door slowly by turning the locking
spindle. This also holds the door whilst it opens. Even if pressure differences exist, the pressure equalisation takes place
until the door is completely open.
Automatic monitoring of the feed water
The quantity and quality of the }feed water is automatically checked before every program start.
Performance characteristics of reprocessing programs
The results in this table show which inspections were performed on the steam sterilizer. The marked fields demonstrate
compliance with all the applicable sections of the standard }EN 13060.
Type tests Universal-B Quick-S Gentle-B Prion-B
Program type in accord-
ance with }EN 13060
Type B Type S Type B Type B
}Dynamic pressure test of
the sterilization chamber
XXXX
}Air leakage XXXX
}Empty chamber test XXXX
}Solid load XXXX
}Porous partial load X -- X X
}Porous full load X -- X X
}Simple hollow bodies XXXX
}Product with narrow lu-
men
X -- X X
}Single wrapping X -- X X
}Multiple wrapping X -- X X
Drying }solid load XXXX
Drying }porous load X -- X X
Sterilization temperature 134 °C 134 °C 121 °C 134 °C
Sterilization pressure 2.1 bar 2.1 bar 1.1 bar 2.1 bar
Sterilization time 5:30min 3:30min 20:30min 20:30min
X = Complies with all applicable sections of the standard }EN 13060

4 Description of the device
4 Description of the device
Scope of delivery
Please check the scope of delivery before setting up and connecting the device.
• Vacuclave 550
• User manual
• User manual Accessories for small steam sterilizers
• Manufacturer's inspection report including declaration of conformity
• Warranty certificate
• Record of installation and setup
• 2x Tray lifter
• MELAG USB flash drive
• Drain hose
• Power cable
• Carrying system
• Allen key for opening the door in an emergency
• Test gauge TR20 for door lock nut
• MELAG oil for door lock nut
• Level increase, tank overflow
• Installation material
12

4 Description of the device
13
Views of the device
View from the front
12
3
4
5
6
1 Access to the validation fitting
2 Feed water tank cover
3 Power switch
4 Opening for door opening in an emer-
gency
5 Door
6 Service hatch
View from front, with open service hatch
7 8 9 10 11 12 13
7 Overheat protection reset button
8 Feed water tank drain valve
9 USB connection
10 Service connection
11 Manometer (double jacket steam gener-
ator)
12 Allen key with which to open the door in
an emergency
13 Dust filter

4 Description of the device
View from the front, with open door
14
15161718
14 Colour touch display
15 Door lock nut
16 Pressure release filter
17 Sterile filter
18 Locking spindle
View from rear
19 20 21 22 23 24
25262728293031
19 USB connection
20 Ethernet connection
21 Overflow funnel
22 Electrical connection, filling pump (op-
tional)
23 Feed water connection of the filling
pump
24 Spring-loaded safety valves
25 Direct drain (optional)
26 Connection for level sensor for external
wastewater container
27 Feed water connection, water treatment
unit
28 Wastewater connection, water treat-
ment unit
29 Wastewater connection
30 Cooler
31 Power cable connection
14

4 Description of the device
15
Symbols on the device
Type plate
Manufacturer of the product
Date of manufacture of the product
MD
Label as medical device
REF
Article number of the product
SN
Serial number of the product
Observe user manual or electronic user manual
Do not dispose of product in household waste
CE marking
0035
Identification number of the notified body responsible for conformity assessment according to Pres-
sure Equipment Directive 2014/68/EU
0197
Identification number of the notified body responsible for conformity assessment according to Regu-
lation (EU) 2017/745 on medical devices
Volume of the sterilization chamber
Working overpressure in sterilization chamber
Operating temperature in sterilization chamber
Electrical connection of the product: Alternating current (AC)
Warning symbols
This symbol indicates that the marked area becomes hot during operation. Contact with it during or
shortly after operation can pose the danger of burns.
This symbol draws attention to an increased danger of crushing resulting from the improper closure
of the steam sterilizer door. Please comply with the instructions outlined in the corresponding chap-
ter.

4 Description of the device
Device symbols - front
Symbol Description Symbol Description
Feed water drain connec-
tion
Overheat protection reset
button
USB connection

Service connection
Device symbols - rear
Symbol Description Symbol Description
Aqua dem Feed water connection,
water treatment unit
Osmosis drain Wastewater connection,
water treatment unit
Pump aqua dem Feed water connection of
the filling pump
Drain Wastewater connection
Pump power Electrical connection, filling
pump (optional)
Sensor drain Sensor of the wastewater
container
Service hatch
The service hatch is magnetic and is opened by pulling on any side.
Power switch
PLEASE NOTE
The device cannot be shut down during a running program.
Press the power switch to open the shutdown dialog.
Press the power switch again to restart the device.
The illumination of the power switch indicates the status of the device.
State Description
illuminated The device is shut down.
not illuminated The device is in standby or a program is running.
pulsing The device is powering up.
16

4 Description of the device
17
Colour touch display
The user interface consists of a colour 7-inch touch display.
The selected menu item is highlighted in colour.
The display of the areas (A, B, C) is dynamic and can change depending on the device status. Due to the dynamic
display, the display and position of the buttons on the device may differ from the illustrations shown.
123 4 5
67
A
B
C
D
1 Login/logout user role
2 Activated/connected output media
3 Program options
4 Starting the program
5 Device status
6 Opening the door
7 Favourites menu*)
A Information area (minimised display)
B Menu area (maximised display)
C Device function area (minimised dis-
play)
D LED status bar
*) recommended programs and func-
tions for quick access
User role symbols
Symbol User role Description
Practice employee Operating the device, making general
settings
Administrator Operating the device, making administra-
tive settings
Service technician Operating the device, making administra-
tive settings and service settings
Symbols of the output media
Symbol Output media Description
MELAtrace Output to MELAtrace
FTP Output to an FTP server
USB flash drive Output to a USB stick connected to the
USB port
Label printer Output to a connected label printer

4 Description of the device
Buttons in the information area
Button Description
Show or hide Device status
Open or close Device status
!
Malfunction message present
Show or hide malfunction message
!
Warning message present
Show or hide warning message
Energy-saving activated
Show or hide energy-saving dialog
Buttons in the program selection
Button Description
Starting the program
Select program options and start program
Aborting/ending the program
LED status bar
The LED status bar on the lowest edge of the display indicates different situations with various colours.
Colour Description
Blue Device is in operation, no program active
Program in progress
Green Program successfully completed
Drying in progress
Red Malfunction message
Program abort in progress
Program not successfully completed
Yellow Warning message
Menu
TheMenu gives you access to the programs available in the
device mode, to various settings and to the log output.
TheSupport menu item contains service contact details and
theLicense information.
18

4 Description of the device
19
Program run
During a program run, all important information is shown on the display.
If no input is made on the display, the program display maximises and overlays the menu. Touch the display to show the
menu.
1 2
8 47 5
6
3
1 Running program
2 Program name
3 Busy indicator
4 Estimated end of the program
5 Program phase
6 Abort/end button
7 Remaining run time (remaining program
duration)
8 Program parameters (temperature/pres-
sure)
The display indicates whether the sterilization phase has been completed successfully. The busy indicator and the LED
status bar both change from blue to green as soon as the drying phase is initiated.
Heat recovery
The Recovery symbol indicates active heat recovery.
The heat of the wastewater is used to heat the feed water. This
means that the feed water has to be heated less. By recovering
this heat, electricity consumption is reduced.
The power recovered through heat recovery is shown in green.
The energy saved over time is displayed in theStatus log.
Load mounts
The device is delivered without a mount for holding trays or cassettes. No mount is necessary for the sterilization of
sterilization containers or MELAstore Box, but MELAG recommends use of the loading slide.
Depending on the typical load, different accessories can be combined with the device.
For detailed instructions on use of the accessories and their combinability with different load carriers, refer to the Mounts
and loading slide [}Page49] section and the "User manual Accessories for small steam sterilizers” document.

5 Installation requirements
5 Installation requirements
Installation location
WARNING
Failure to comply with the setup conditions can result in injuries and/or damage to the device.
nThe steam sterilizer should only be setup, installed and commissioned by persons authorised by MELAG.
nThe steam sterilizer is not suitable for operation in explosive atmospheres.
nThe steam sterilizer is conceived for use outside the patient care area. The device should be located a
minimum of 1.5m radius away from the treatment area.
Steam egress can occur during operation. Do not set up the device in the immediate proximity of a smoke detector.
Maintain clearance from materials which could suffer damage from steam.
Make sure that the ambient conditions meet the requirements, see Technical data [}Page93]
Electromagnetic environments
When assessing the Electromagnetic Compatibility (EMC) of this device, the emitted interference threshold values for
Class B devices and the stability for operation in an electromagnetic environment as described in IEC 61326-1 were
taken as the basis. The device is thus suitable for operation in all institutions and domestic settings connected to a public
mains power supply. The floor should be made of wood or concrete or be tiled with ceramic tiling. If the floor is fitted with
synthetic material, the relative humidity must amount to a minimum of 30%.
20