Durr Dental Hygoclave 90 Operating instructions

EN
Hygoclave 90
Installation and operating instructions
0297
6046100064L02
*6046100064L02*
2007V003

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended purpose .. . . . . . . . . . . 4
2.2 Indications .. . . . . . . . . . . . . . . . . 4
2.3 Contraindications .. . . . . . . . . . . . 4
2.4 Intended use .. . . . . . . . . . . . . . . 4
2.5 Improper use .. . . . . . . . . . . . . . . 4
2.6 General safety information .. . . . . 5
2.7 Systems, connection with other
devices .. . . . . . . . . . . . . . . . . . . 5
2.8 Standards .. . . . . . . . . . . . . . . . . 5
2.9 Specialist personnel .. . . . . . . . . 5
2.10 Electrical safety .. . . . . . . . . . . . . 6
2.11 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 6
2.12 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 6
2.13 Only use original parts .. . . . . . . . 6
2.14 Transport and packaging .. . . . . . 6
2.15 Disposal .. . . . . . . . . . . . . . . . . . 6
2.16 Protection from threats from the
Internet .. . . . . . . . . . . . . . . . . . . 6
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Scope of delivery .. . . . . . . . . . . . 9
3.2 Accessories .. . . . . . . . . . . . . . . . 9
3.3 Optional items .. . . . . . . . . . . . . . 9
3.4 Consumables .. . . . . . . . . . . . . . 9
3.5 Wear parts and replacement
parts .. . . . . . . . . . . . . . . . . . . . . 9
4Technical data .. . . . . . . . . . . . . . . . . . . 10
4.1 Type plate .. . . . . . . . . . . . . . . . . 12
4.2 Evaluation of conformity .. . . . . . 12
5 Operation .. . . . . . . . . . . . . . . . . . . . . . 13
5.1 Hygoclave 90 .. . . . . . . . . . . . . . 13
5.2 Safety devices .. . . . . . . . . . . . . . 15
5.3 Overview of programs .. . . . . . . . 17
Assembly
6 Requirements .. . . . . . . . . . . . . . . . . . . 18
6.1 Installation/setup room .. . . . . . . 18
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 18
7.1 Carrying the unit .. . . . . . . . . . . . 18
7.2 Remove the transport locks .. . . 18
7.3 Setting up the unit .. . . . . . . . . . . 18
7.4 Removing the protective film
from the touch screen .. . . . . . . . 19
7.5 Checking the SD memory card .. 19
7.6 Checking the air filter .. . . . . . . . . 20
7.7 Connecting the unit .. . . . . . . . . . 20
7.8 Connecting the device to the
network .. . . . . . . . . . . . . . . . . . . 22
7.9 Connecting a label printer .. . . . . 22
8Configuring the unit .. . . . . . . . . . . . . . 24
8.1 Selecting the access level .. . . . . 24
8.2 Entering dealer information .. . . . 24
8.3 Language selection .. . . . . . . . . . 24
8.4 Configuring the device with a
network connection .. . . . . . . . . . 24
8.5 Set the date and time. .. . . . . . . . 24
8.6 Parameter selection .. . . . . . . . . . 25
8.7 Configuring a log printer .. . . . . . 25
8.8 Configuring the label printer .. . . . 25
8.9 Configuring the network drive .. . 25
8.10 Monitoring the unit via the net-
work .. . . . . . . . . . . . . . . . . . . . . 26
8.11 User management .. . . . . . . . . . . 27
8.12 Setting up the calendar .. . . . . . . 27
8.13 Touch screen .. . . . . . . . . . . . . . . 27
8.14 Resetting counter readings .. . . . 28
9Test programs .. . . . . . . . . . . . . . . . . . . 28
9.1 Vacuum test .. . . . . . . . . . . . . . . 28
9.2 Bowie-Dick test .. . . . . . . . . . . . . 29
10 Validation for commissioning .. . . . . . . 29
Contents
6046100064L02 2007V003 1
EN

11 Handover record .. . . . . . . . . . . . . . . . . 30
Usage
12 Operation .. . . . . . . . . . . . . . . . . . . . . . 31
12.1 Switching the unit on/off .. . . . . . 31
12.2 Touch screen .. . . . . . . . . . . . . . . 31
12.3 Time preset .. . . . . . . . . . . . . . . . 34
12.4 Opening and closing the door .. . 34
12.5 Preparations for steam sterilisa-
tion .. . . . . . . . . . . . . . . . . . . . . . 35
12.6 Loading the items for sterilisation
into the unit .. . . . . . . . . . . . . . . . 37
12.7 Steam sterilising .. . . . . . . . . . . . 38
12.8 Storing parts for sterilisation .. . . 41
13 Documenting the sterilisation .. . . . . . 41
13.1 Batch documentation .. . . . . . . . 41
13.2 Automatic record output .. . . . . . 42
13.3 Subsequent output of saved
records .. . . . . . . . . . . . . . . . . . . 42
13.4 Printing logs (reports) .. . . . . . . . . 42
13.5 Print labels .. . . . . . . . . . . . . . . . 45
14 Messages on the touch screen .. . . . . 46
14.1 Note .. . . . . . . . . . . . . . . . . . . . . 46
14.2 Information .. . . . . . . . . . . . . . . . 47
15 Operating pauses .. . . . . . . . . . . . . . . . 48
15.1 Pause times .. . . . . . . . . . . . . . . 48
16 Taking out of operation .. . . . . . . . . . . 48
16.1 Transport .. . . . . . . . . . . . . . . . . . 48
17 Restarting after an extended pause in
operation .. . . . . . . . . . . . . . . . . . . . . . . 49
18 Maintenance .. . . . . . . . . . . . . . . . . . . . 50
18.1 Maintenance schedule .. . . . . . . . 50
18.2 Complete cleaning .. . . . . . . . . . 52
18.3 Cleaning or replacing the door
seal .. . . . . . . . . . . . . . . . . . . . . . 54
18.4 Checking the hinge and lubricat-
ing the door spindle .. . . . . . . . . 55
18.5 Clean or replacing water filters .. . 55
18.6 Replacing the air filter .. . . . . . . . 56
18.7 Firmware update .. . . . . . . . . . . . 56
18.8 Function check .. . . . . . . . . . . . . 56
Troubleshooting
19 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 57
19.1 "Notice" messages .. . . . . . . . . . 57
19.2 "Fault" messages .. . . . . . . . . . . 58
20 Emergency opening of the door .. . . . 60
Appendix
21 Menu structure .. . . . . . . . . . . . . . . . . . 61
21.1 Settings .. . . . . . . . . . . . . . . . . . . 61
21.2 Actions .. . . . . . . . . . . . . . . . . . . 62
22 Handover record .. . . . . . . . . . . . . . . . . 63
Contents
2 6046100064L02 2007V003
EN

Important information
1 About this document
These installation and operating instructions rep-
resent part of the unit.
If the instructions and information in these
installation and operating instructions are
not followed, Dürr Dental will not be able
to offer any warranty or assume any liabil-
ity for the safe operation and the safe
functioning of the unit.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translation of the original manual.
These operating instructions apply to Hygo-
clave 90:
Order number: 6046-01
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
Warning – dangerous high voltage
Warning – hot surfaces
The warnings are structured as follows:
SIGNAL WORD
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
❯Follow these measures to avoid the
danger.
The signal word differentiates between four levels
of danger:
–DANGER
Immediate danger of severe injury or death
–WARNING
Possible danger of severe injury or death
–CAUTION
Risk of minor injuries
–NOTICE
Risk of extensive material/property damage
Other symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Observe the operating instructions.
0297
CE labelling with the number of the noti-
fied body
Manufacturer
Medical device
Serial number
Order number
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
On/off switch
Monitor ambient conditions
Steam sterilise at 134 °C
Fresh water
Waste water
Important information
6046100064L02 2007V003 3
EN

Wear protective gloves.
Disconnect all power from the unit.
1.2 Copyright information
All circuits, processes, names, software pro-
grams and units mentioned in this document are
protected by copyright.
The Installation and Operating Instructions must
not be copied or reprinted, neither in full nor in
part, without written authorisation from Dürr Den-
tal.
2 Safety
Dürr Dental has designed and constructed this
unit so that when used properly and for the inten-
ded purpose it does not pose any danger to
people or property.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects on skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended purpose
The Hygoclave is a small steam steriliser in
accordance with DIN EN 13060 and is designed
for medical use.
2.2 Indications
None
2.3 Contraindications
None
2.4 Intended use
The programs offered by the steam steriliser ena-
ble the selection of 'type B' sterilisation cycles.
This means that it can be used to sterilise bulky
products, porous products and products with a
narrow lumen, packaged (single or multi-layer) or
unpackaged.
Before sterilising any medical devices, also refer
to the information provided by the manufacturers
of these medical devices (refer also to EN ISO
17664).
2.5 Improper use
Any use of this appliance / these appliances
above and beyond that described in the Installa-
tion and Operating Instructions is deemed to be
incorrect usage. The manufacturer cannot be
held liable for any damage resulting from incor-
rect usage. The operator will be held liable and
bears all risks.
Important information
4 6046100064L02 2007V003
EN

WARNING
The sterilisation of liquids can cause a
risk of explosion, risk of burns, boiling
retardation and vapours that are haz-
ardous to health.
❯Do not sterilise liquids in the unit.
WARNING
Risk of explosion due to ignition of
combustible materials
❯Do not operate the unit in any rooms in
which inflammable mixtures may be
present, e.g. in operating theatres.
NOTICE
Damage to the unit or to the items
being sterilised due to unsuitable
materials
❯Only sterilise instruments, packaging
and textiles that are suitable for steam
sterilisation according to the manufac-
turer's information.
2.6 General safety information
❯Always comply with the specifications of all
guidelines, laws, and other rules and regula-
tions applicable at the site of operation for the
operation of this unit.
❯Check the function and condition of the unit
prior to every use.
❯Do not convert or modify the unit.
❯Comply with the specifications of the Installa-
tion and Operating Instructions.
❯The Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
2.7 Systems, connection with
other devices
Take care when connecting units together or to
parts of other systems as there is always an ele-
ment of risk (e.g. due to leakage currents).
❯Only connect units when there can be no
question of danger to operator or to patient.
❯Only connect units when it is safe to do so and
when there is no risk of damage or harm to the
surroundings.
❯If it is not 100% clear from the unit data sheet
that such connections can be safely made or if
you are in any doubt, always get a suitably
qualified person (e.g. the manufacturer) to ver-
ify that the setup is safe.
Where applicable, the requirements for medical
products have been taken into account in the
development and construction of the device. As
a result, this device is suitable for installation
within medical supply equipment.
❯Where this device is integrated in other medical
supply equipment, the requirements of Euro-
pean Union Medical Device Regula-
tion 2017/745 and the relevant standards must
be observed.
2.8 Standards
In their current version.
DIN EN 13060
Small steam sterilisers.
EN 61010-1
Safety requirements for electrical equipment for
measurement, control and laboratory use.
EN 61010-2-040
Safety requirements for electrical equipment for
measurement, control and laboratory use – Part
2-040: Particular requirements for sterilisers and
washer-disinfectors used to treat medical materi-
als.
EN 61326-1
Electrical measurement, instrumentation, control
and laboratory equipment
2.9 Specialist personnel
Operation
Unit operating personnel must ensure safe and
correct handling based on their training and
knowledge.
❯Instruct or have every user instructed in han-
dling the unit.
❯Regularly train all users who are responsible for
use and maintenance of the device. As part of
this, the operators must also demonstrate that
they have understood everything covered.
Attendance lists of the training course partici-
pants must also be kept.
Important information
6046100064L02 2007V003 5
EN

Installation and repairs
❯Installation, readjustments, alterations,
upgrades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental.
2.10 Electrical safety
❯Observe and comply with all the relevant elec-
trical safety regulations when working on the
unit.
❯Replace any damaged cables or plugs immedi-
ately.
2.11 Essential performance char-
acteristics
The unit does not have any essential perform-
ance characteristics as set out in IEC 60601-1
section 4.3.
2.12 Notification requirement of
serious incidents
The operator/patient is required to report any
serious incident that occurs in connection with
the device to the manufacturer and to the com-
petent authority of the Member State in which
the operator and/or patient is established/resi-
dent.
2.13 Only use original parts
❯Only use accessories and optional items that
have been recommended or specifically
approved by Dürr Dental.
❯Only use only original wear parts and replace-
ment parts.
2.14 Transport and packaging
The original packaging provides optimum protec-
tion for the unit during transport.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental will not accept any responsi-
bility or liability for damage occurring dur-
ing transport due to the use of incorrect
packaging, even where the unit is still
under guarantee.
❯Only transport the unit in its original packaging.
❯Keep the packing materials out of the reach of
children.
2.15 Disposal
Unit
The unit may be contaminated. Instruct
the company disposing of the waste to
take the relevant safety precautions.
❯Decontaminate potentially contaminated parts
before disposing of them.
❯Uncontaminated parts (e.g. electronics, plastic
and metal parts etc.) should be disposed of in
accordance with the local waste disposal regu-
lations.
❯If you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
An overview of the waste keys for Dürr
Dental products can be found in the
download area at www.duerrdental.com
(document no. P007100155).
Decontamination of potentially contaminated
parts
The following parts of the device may be conta-
minated.
– Sterilisation chamber
– Water container
– Water-carrying lines
In order to properly dispose of the potentially
contaminated parts, they must first be decon-
taminated. To do this, carry out the following
steps:
❯Empty the water containers.
❯Remove all fixed connections for fresh water
and waste water.
❯Wipe-disinfect the inner surfaces of the water
containers with a surface disinfectant, e.g.
FD 322 or FD 333 from Dürr Dental.
❯Once the inner surfaces of the water containers
have dried off, fill the fresh water container with
demineralized fresh water (see "7.7 Connect-
ing the unit").
❯Run 2-3 cycles of the quick program.
❯Empty the water containers and wipe-disinfect
them.
2.16 Protection from threats from
the Internet
The unit is to be connected to a computer that
can be connected to the Internet. Therefore, the
Important information
6 6046100064L02 2007V003
EN

system needs to be protected from threats from
the Internet.
❯Use antivirus software and update it regularly.
Look for evidence of possible virus infection
and, if applicable, check with the antivirus soft-
ware and remove the virus.
❯Perform regular data backups.
❯Restrict access to units to trustworthy users,
e.g. via a user name and password.
❯Make sure that only trustworthy content is
downloaded. Only install software and firmware
updates that have been authenticated by the
manufacturer.
Important information
6046100064L02 2007V003 7
EN

Product description
3 Overview
1
2
3
4
8
9
5
6
7
10
11
12
1 Steam steriliser Hygoclave 90
2 Air filters
3 SD memory card
4 Network cable
5 Mains cable
6 Door seal
7 Tray handle
8 Tray
9 Carrier, rotatable, for 6 trays or 3 standard tray cassettes
10 Drain hose for waste water and fresh water
11 Water drain hose for "automatic water discharge"
12 Stylus with magnetic holder
Product description
8 6046100064L02 2007V003
EN

3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
Hygoclave 90 .. . . . . . . . . . . . . . . . . . . 6046-01
– Carrier for trays or standard tray cassettes
– Trays
– Tray handle
– SD memory card
– Stylus with magnetic holder
– Drain hose for manual emptying of fresh and
waste water on the fore side of the device
– Water drain hose for "automatic water dis-
charge" on the rear side of the device
– Water filter set
– Hexagon key for emergency unlocking
– Air filters
– Hygotest, starter kit
– Network cable
– Mains cable
– Software "Tyscor Pulse"
– Installation and operating instructions
– Handover and installation record
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
Tray (perforated) .. . . . . . . . . . . . . . 6046100112
3.3 Optional items
The following optional items can be used with the
device:
Hygoprint Plus
(label printer, network capable) .. . . 6046100035
Labelling set for
Hygoprint Plus .. . . . . . . . . . . . . . . . 6046100130
Hygopure 90
(reverse osmosis system) .. . . . . . . . 6046100017
Hygodem 90 (ion exchanger) .. . . . . 6046100114
Hygotest (Helix test bodies
with test strips) .. . . . . . . . . . . . . . . 6050-600-03
3.4 Consumables
The following materials are consumed during
operation of the device and must be ordered
separately:
FD 333
rapid surface disinfection .. . . . . . CDF333C6150
FD 350 Classic
disinfection wipes .. . . . . . . . . . . CDF35CA0140
3.5 Wear parts and replacement
parts
The following working parts need to be changed
at regular intervals (refer to the "Maintenance"
section):
Air filters .. . . . . . . . . . . . . . . . . . . . 6046-000-14
Door seal .. . . . . . . . . . . . . . . . . . . . 6046100080
Tray handle .. . . . . . . . . . . . . . . . . . 6046100102
Stylus with magnetic holder .. . . . . . 6046100129
Water filter set .. . . . . . . . . . . . . . . . 6046100132
Drain hose for manual emptying of
fresh water and waste water on the
front side of the device .. . . . . . . . . 6046100105
Water drain hose for "automatic
water discharge" on the rear side of
the device .. . . . . . . . . . . . . . . . . . . 6046100128
Lubricant .. . . . . . . . . . . . . . . . . . . . 9000474001
Information about replacement parts is
available from the portal for authorised
specialist dealers at:
www.duerrdental.net.
Product description
6046100064L02 2007V003 9
EN

4 Technical data
Electrical data for the unit
Rated voltage V AC 230
Mains frequency Hz 50
Rated power W 2600
Fuses 2 x T 12 AH / 250 V~ (IEC 60127)
General technical data of device
Dimensions (H x W x D) cm 58 x 54 x 47.5
Weight, empty kg 62
Other technical data
Heat output at 23 °C MJ/h 6.5
Noise level * dB(A) < 66
Operating mode Continuous operation
Capacity of fresh water container l approx. 4
Capacity of waste water container l approx. 4
Operating pressure (absolute) max. kPa 325
Operating pressure (absolute) min. kPa approx. 5
Response pressure (relative), safety valve bar 2.55
Water and dust protection (IEC 60529) IP 20
* in accordance with EN ISO 3746
Technical data for the sterilisation chamber
Internal dimensions, useable volume (Æx
D)
cm 26 x 35
Volume l 19
Load capacity (unpackaged instruments)
Bulky hollow instruments
Porous materials
kg
kg
6
2
Sterilisation temperature in accordance
with EN 13060
°C 134 + 3
Heat-up time, at room temperature min approx. 22
Sterilisation hold time, program-dependent min 5.5 - 20.5
Drying time, program-dependent min 10.5 - 16
Ambient conditions during storage and transport
Temperature °C -10 to +60
Relative humidity % < 75
Ambient conditions during operation
Temperature °C +15 to +35
Product description
10 6046100064L02 2007V003
EN

Ambient conditions during operation
Relative humidity % 30 - 75
Air pressure hPa 750 to 1060
Altitude above mean sea level m < 2000
Internal memory
Memory capacity 4,500 cycles
Connection for "automatic fresh water supply connection"
Union nut " 3/4
Screw-in connector " 3/8
Running water pressure bar (kPa) 1.5 - 5.5 (150 - 550)
Drain hose
Hose length m 1.50
Network connection
LAN technology Ethernet
Standard IEEE 802.3u
Data rate Mbit/s 100
Connector RJ45
Type of connection Auto MDI-X
Cable type ³CAT5
Classification
Medical Device Class IIa
Electromagnetic compatibility (EMC)
High-frequency emissions in accordance
with CISPR 11
Group 1
Class B
Mains impedance, in accordance with
IEC 61000-3-11
Ω < 0.1
Harmonics in acc. with IEC 61000-3-2 Not applicable
Voltage fluctuations/flickers in acc. with
IEC 61000-3-3
Not applicable
Conducted high-frequency disturbance
variable V1in acc. with IEC 61000-4-6
Veff 3
Emitted high-frequency disturbance varia-
ble E1in accordance with IEC 61000-4-3
V/m 4
Product description
6046100064L02 2007V003 11
EN

4.1 Type plate
The type plate is located on the rear of the
device.
4.2 Evaluation of conformity
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant European Union guidelines. This
equipment conforms to all relevant requirements.
Product description
12 6046100064L02 2007V003
EN

5 Operation
5.1 Hygoclave 90
1
2
3
4
5
11
12
13
14
15
8
10
9
SD
6
7
16
17
18
19
1 Cover for waste water container and fresh
water container
2 Touch screen
3 On / off switch
4 SD memory card slot
5 Air filters
6 Connection (quick release coupling) for
"manual waste water emptying"
7 Connection (quick release coupling) for
"manual fresh water emptying"
8 Condenser
9 Pressure gauge cover
10 Motor shaft cover
11 Electrical connections
12 Network connection
13 Connection for "automatic water drain"
14 Connection for "automatic fresh water
supply connection"
15 Roller feet, for positioning of the unit
16 Sterilisation chamber
17 Door seal
18 Door spindle
19 Adjustable feet, for height adjustment of
the unit
The Hygoclave 90 small steam steriliser is used
to sterilise objects with steam at temperatures of
121 °C or 134 °C under pressure.
The unit sterilises on the basis of the fractionated
vacuum method. This ensures that the objects
being sterilised are wetted or penetrated with
saturated steam. This method is suitable for
steam sterilisation of all loads that will be encoun-
tered in a medical practice.
The sterilisation chamber is protected against
overheating.
Use fresh distilled or demineralised water for
every sterilisation process.
Vacuum phase
A vacuum is generated in several phases
depending on the program.
Sterilisation phase
Saturated steam is generated inside the steriliser
chamber until the specified values are reached.
The actual sterilisation takes place during the
predefined hold time.
Drying phase
The parts for sterilisation in the sterilisation cham-
ber are dried under vacuum. Afterwards the steri-
lisation chamber is vented via the air filter and the
door can be opened.
Product description
6046100064L02 2007V003 13
EN

Vacuum drying ensures optimum drying results
even when the parts for sterilisation are pack-
aged.
Sterilisation chamber
The capacity of the sterilisation chamber is 19
litres. It can be filled with a load according to
demand.
The maximum load depends on the load type
and the selected program.
Steam generator and heating system
The device has a high-performance steam gener-
ator. This is coupled to an insulated heating sys-
tem (heat pipe), which fully encloses the sterilisa-
tion chamber. This unique combination ensures
fast process times and very good drying results.
Steam condenser and vacuum pump
The combination of steam condenser and vac-
uum pump, which has been specially developed
for steam sterilisation, enables reliable and fast
generation of a deep vacuum in all phases of the
process.
The resulting high venting capacity ensures the
very good sterilisation and drying results.
Carrier, trays, standard tray cassettes
The carrier can be loaded with up to 6 trays or –
rotated through 90° – 3 standard tray cassettes.
Water container
MIN
MAX
1
1
2
1 Fresh water container
2 Waste water container
The unit is equipped with a fresh water container
(left-hand side) and a waste water container
(right-hand side). The maximum capacity of each
container is 4 litres.
Depending on the selected program and the
load, an average of approx. 7 sterilisation cycles
is possible.
The minimum and maximum fill levels are detec-
ted via a water level sensor.
Fresh water supply
The supply with fresh water is provided either via
the internal fresh water container or via an exter-
nal water treatment system, which is connected
to the in-house water supply.
Only use high-quality distilled or demineralised
water. Guideline values for water quality in
accordance with DINEN 13060 Appendix C.
If a water treatment system is connected there is
no need to fill up the fresh water container.
Waste water emptying
The waste water is collected in the waste water
container at the end of each cycle.
The waste water can be manually emptied or,
when connected to the central sewerage system,
drain off automatically.
Water treatment system
With the aid of a water treatment system it is
possible to produce water with optimum fresh
water quality for steam generation in the unit.
The water treatment system is connected to the
fresh water connection of the unit and to the in-
house water supply.
Product description
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Altitude
Adjustments for altitude (above mean sea
level) and therefore to the ambient pres-
sure are performed automatically.
Operating elements
1
2
ON
OFF
2 sec
5 sec
1 Touch screen
2 On / off switch
The touch screen can be used to adjust settings
on the device and select programs. Instructions
can be entered on the touch screen either with
the tip of a finger or with a stylus.
Start screen on the touch screen
Batch documentation
The device has an internal memory in which all
data for completed cycles (4,500 cycles) is auto-
matically saved.
In order to enable effective batch documentation
and subsequent checking of completed pro-
grams, the record can be saved immediately
after the end of the cycle and output at a later
time.
The record data can be further processed in vari-
ous ways:
– saved to an SD memory card
– saved to a network storage location
– printed out via a network printer
– forwarded to document creation software
5.2 Safety devices
The unit has several safety devices for protecting
the operator, patient and unit:
– Safety door latch
– Fresh water check
– Electronic parameter control
– Process evaluation system
– Safety valve
– Additional function check
If one or more of the parameter(s) exceed the
specified limit values, the unit outputs warnings
or fault messages and cancels the program if
necessary.
If the program is cancelled a message will be dis-
played on the touch screen.
Safety door latch
The device continuously monitors the pressure
and temperature and will not allow the door to be
opened if overpressure is present in the sterilisa-
tion chamber. The automatic door latch ensures
that the door only opens slowly (by rotating the
door spindle). Even in the case of pressure differ-
ences, pressure equalisation takes place until the
door is fully opened.
Fresh water check
Each time the program is started an automatic
check of the fresh water is performed via an inte-
grated conductivity measurement. This ensures
that specified values are not exceeded. Stains on
instruments and contamination of the unit are
prevented (assuming careful instrument prepara-
tion).
Electronic parameter control
The device operates with electronic parameter
control. Values for pressure, temperature and
time are automatically monitored in the pro-
grams. This ensures that the total running time of
a program is optimised depending on the load.
Process evaluation system
The process evaluation system monitors and
compares ACTUAL process parameters with
TARGET process parameters. In this way, faults
in the program sequence can be detected and
correct sterilisation results can be ensured.
Product description
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EN

Safety valve
A safety valve ensures pressure is released if the
pressure is higher than 2.6 bar.
Additional function check
With the aid of test programs, it is possible to
perform additional function checks at any time:
– Check the device for leakages in the steam
system with the vacuum test
– Use the Bowie-Dick test to check that the
steam penetration of porous items for sterilisa-
tion (e.g. textiles) is sufficient.
Product description
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5.3 Overview of programs
Type tests Universal
program
Quick pro-
gram
Gentle pro-
gram
Prions pro-
gram
Programme type in accordance with EN
13060
Type B Type B Type B Type B
Dynamic pressure testing of the sterilisation
chamber
X X X X
Air leakage X X X X
Empty chamber test X X X X
Bulky load X X X X
Porous partial load X X X
Porous full load X X X
Hollow body B X X X X
Hollow body A X X X X
Single packaging X X X X
Multiple packaging X X X
Drying, bulky load X X X X
Drying, porous load X X X
Sterilising temperature 134°C 134°C 121°C 134°C
Steriliser pressure (absolute) 312.0 kPa 312.0 kPa 210.7 kPa 312.0 kPa
Hold time 5.5 min 5.5 min 20.5 min 20 min
Max. bulky load 10 kg 6 kg 6 kg 10 kg
Max. single weight (e.g. load on tray, stand-
ard tray cassettes)
3.3 kg 2 kg 2 kg 3.3 kg
Max. massive load in containers 10 kg 6 kg 10 kg
Max. single-packed, bulky load 6 kg 1.5 kg 6 kg 6 kg
Max. double-packed, bulky load 6 kg 6 kg 6 kg
Max. porous load 2 kg 2 kg 2 kg
Max. single-packed, porous load 2 kg 2 kg 2 kg
Max. double packed, porous load 2 kg 2 kg 2 kg
X = compliance with all applicable sections of standard DIN EN 13060
Product description
6046100064L02 2007V003 17
EN

Assembly
6 Requirements
6.1 Installation/setup room
The room chosen for installation must satisfy the
following requirements:
– Solid, horizontal ground/floor
– Closed, dry, dust-protected interior room.
Should not be a room made for another pur-
pose (e. g. boiler room or wet cell)
– The specified minimum distances between the
unit and the wall, to the side and to the top
must be complied with (see "7.3 Setting up
the unit").
– Room chosen for set-up must be well ventila-
ted
– No flammable gases in the proximity of the unit
– Observe the required ambient conditions (see
"4 Technical data").
– Mains cable plug connections must be freely
accessible so they can be quickly disconnec-
ted if there is any danger.
7 Installation
7.1 Carrying the unit
❯The unit must only be carried by two persons.
❯Use suitable carrying aids if necessary.

2x
7.2 Remove the transport locks
❯Remove the internal and external packaging
materials and transport protection.
7.3 Setting up the unit
The unit is intended for operation outside the
patient environment.
The following gaps/distances must be main-
tained:
– To the treatment chair: min. radius of 1.5 m
– To the rear wall: at least 10 cm
– To the sides: at least 5 cm
– To the top: at least 20 cm
The unit should be freely accessible that the
integrated fresh water container can be filled
and to ensure good ventilation.
10 cm
85
kg
Assembly
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