Durr Dental Hygoclave 90 User manual

EN
1702V002SE
6046100064L02

Installation and Operating Instructions
Hygoclave 90
0297

6046100064L02 1702V002SE 1
7 Installation � � � � � � � � � � � � � � � � � � � � � � 17
7�1 Carrying the unit � � � � � � � � � � � � � � 17
7�2 Remove the transport locks � � � � � 17
7�3 Setting up the unit� � � � � � � � � � � � � 17
7�4 Removing the protective film from
the touch screen� � � � � � � � � � � � � � 18
7�5 Checking the SD memory card � � � 18
7�6 Checking the sterile air filter� � � � � � 18
7�7 Connecting the unit� � � � � � � � � � � � 19
7�8 Connecting the unit to the net-
work � � � � � � � � � � � � � � � � � � � � � � � 20
8 Configuring the unit � � � � � � � � � � � � � � � 22
8�1 Selecting the access level � � � � � � � 22
8�2 Entering dealer information � � � � � � 22
8�3 Language selection� � � � � � � � � � � � 22
8�4 Configuring the device with a
network connection � � � � � � � � � � � 22
8�5 Set the date and time�� � � � � � � � � � 22
8�6 Parameter selection � � � � � � � � � � � 23
8�7 Configuring a log printer � � � � � � � � 23
8�8 Configuring the label printer � � � � � 23
8�9 Configuring the network drive � � � � 23
8�10 User management � � � � � � � � � � � � 24
8�11 Setting up the calendar � � � � � � � � � 24
8�12 Touch screen � � � � � � � � � � � � � � � � 25
9 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � � � � � 25
9�1 Network configuration � � � � � � � � � � 25
9�2 Network protocols and ports� � � � � 25
9�3 Add device � � � � � � � � � � � � � � � � � � 26
10 Test programs � � � � � � � � � � � � � � � � � � � 27
10�1 Vacuum test � � � � � � � � � � � � � � � � � 27
10�2 Bowie-Dick test � � � � � � � � � � � � � � 27
11 Logging handover and installation � � � � 28
12 Validation for commissioning � � � � � � � � 28
Operation
13 Operation � � � � � � � � � � � � � � � � � � � � � � � 30
13�1 Switching the unit on/off � � � � � � � � 30
13�2 Touch screen � � � � � � � � � � � � � � � � 30
13�3 Time preset� � � � � � � � � � � � � � � � � � 32
13�4 Monitoring the device with
Tyscor Pulse � � � � � � � � � � � � � � � � � 32
13�5 Opening and closing the door � � � � 33
EN
Contents
Important information
1 About this document � � � � � � � � � � � � � � � 3
1�1 Warnings and symbols � � � � � � � � � � 3
1�2 Copyright information � � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
2�1 Intended purpose � � � � � � � � � � � � � � 4
2�2 Intended use� � � � � � � � � � � � � � � � � � 4
2�3 Improper use � � � � � � � � � � � � � � � � � 4
2�4 General safety information� � � � � � � � 4
2�5 Applicable guidelines and
standards � � � � � � � � � � � � � � � � � � � � 4
2�6 Qualified personnel � � � � � � � � � � � � � 5
2�7 Protection from electric shock � � � � � 5
2�8 Only use genuine parts � � � � � � � � � � 5
2�9 Transport and packaging� � � � � � � � � 5
2�10 Disposal � � � � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � � � � 6
3�1 Scope of delivery � � � � � � � � � � � � � � 7
3�2 Accessories � � � � � � � � � � � � � � � � � � 7
3�3 Special accessories � � � � � � � � � � � � 7
3�4 Disposable materials � � � � � � � � � � � � 7
3�5 Wear parts and spare parts� � � � � � � 7
4 Technical data � � � � � � � � � � � � � � � � � � � � 8
4�1 Type plate � � � � � � � � � � � � � � � � � � � 10
4�2 Conformity assessment� � � � � � � � � 10
5 Operation � � � � � � � � � � � � � � � � � � � � � � � 11
5�1 Hygoclave 90 � � � � � � � � � � � � � � � � 11
5�2 Safety devices � � � � � � � � � � � � � � � 13
5�3 Overview of programs � � � � � � � � � � 15
5�4 Tyscor Pulse (optional) � � � � � � � � � 15
Installation
6 Requirements � � � � � � � � � � � � � � � � � � � � 17
6�1 Installation/setup room � � � � � � � � � 17

2 6046100064L02 1702V002SE
Contents
13�6 Preparations for steam
sterilisation � � � � � � � � � � � � � � � � � � 34
13�7 Loading the items for sterilisation
into the unit� � � � � � � � � � � � � � � � � � 36
13�8 Steam sterilising � � � � � � � � � � � � � � 37
13�9 Storing parts for sterilisation � � � � � 39
14 Documenting the sterilisation� � � � � � � � 40
14�1 Batch documentation � � � � � � � � � � 40
14�2 Automatic record output � � � � � � � � 41
14�3 Subsequent output of saved
records � � � � � � � � � � � � � � � � � � � � � 41
14�4 Printing out records� � � � � � � � � � � � 41
15 Messages on the touch screen � � � � � � 43
15�1 Note � � � � � � � � � � � � � � � � � � � � � � � 43
15�2 Information � � � � � � � � � � � � � � � � � � 43
16 Operating pauses � � � � � � � � � � � � � � � � � 45
16�1 Pause times � � � � � � � � � � � � � � � � � 45
17 Taking out of operation � � � � � � � � � � � � 45
17�1 Transport � � � � � � � � � � � � � � � � � � � 45
18 Restarting after an extended pause in
operation � � � � � � � � � � � � � � � � � � � � � � � 46
19 Maintenance� � � � � � � � � � � � � � � � � � � � � 47
19�1 Maintenance schedule � � � � � � � � � 47
19�2 Complete cleaning � � � � � � � � � � � � 48
19�3 Cleaning or replacing the door
seal � � � � � � � � � � � � � � � � � � � � � � � 50
19�4 Checking the hinge and oiling the
door spindle � � � � � � � � � � � � � � � � � 50
19�5 Clean or replacing water filters � � � 51
19�6 Changing the sterile air filter � � � � � 51
19�7 Function check � � � � � � � � � � � � � � � 52
Troubleshooting
20 Tips for operators and
service technicians� � � � � � � � � � � � � � � � 53
20�1 "Caution" messages � � � � � � � � � � � 53
20�2 "Fault" messages � � � � � � � � � � � � � 53
21 Emergency opening of the door� � � � � � 55
Appendix
22 Settings menu layout � � � � � � � � � � � � � � 56
EN

6046100064L02 1702V002SE 3
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�
Take note of the accompanying
documents�
0297 CE labelling with the number of the
notified body
Manufacturer
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE)�
Serial number
Order number
On/off switch
Monitor ambient conditions
Steam sterilise at 134 °C
Fresh water
Waste water
Wear hand protection�
Switch off and de-energise the device
(e�g� unplug from mains)�
1.2 Copyright information
All names of circuits, processes, names, soft-
ware programs and units used 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
Dental�
1 About this document
These installation and operating instructions
form part of the unit�
If the instructions and information in
these installation and operating instruc-
tions are not followed, Dürr Dental will
not be able to offer any warranty or as-
sume any liability for the safe operation
and the safe functioning of the unit�
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
iFollow 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
Important information
EN

4 6046100064L02 1702V002SE
Important information
NOTICE
Damage to the unit or to the items
being sterilised due to unsuitable
materials
iOnly sterilise instruments, packaging
and textiles that are suitable for steam
sterilisation according to the manufac-
turer's information�
2.4 General safety information
iWhen operating this device always observe all
guidelines, laws, and other rules and regula-
tions that are applicable at the site of opera-
tion�
iPrior to each use, check condition of the de-
vice and make sure it is in perfect working
order�
iDo not convert or modify the units�
iObserve the Installation and Operating
Instructions�
iMake the Installation and Operating Instruc-
tions available to the person operating the
device at all times�
2.5 Applicable guidelines and
standards
Guidelines
Medical Devices Directive
93/42/EEC Directive on Medical Devices� In its
current version�
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 mate-
rials�
EN 61326-1
Electrical equipment for measurement, control
and laboratory use – EMC requirements
2 Safety
Dürr Dental has designed and constructed this
device so that when used properly and for the
intended purpose there is no danger to people
or property� Nevertheless, residual risks can re-
main� You should therefore observe the follow-
ing notes�
2.1 Intended purpose
The Hygoclave is a small steam steriliser in ac-
cordance with DIN EN 13060 and is designed
for medical use�
2.2 Intended use
The programs offered by the steam steriliser en-
able 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 manufactur-
ers of these medical devices (refer also to EN
ISO 17664)�
2.3 Improper use
Any other usage or usage beyond this scope is
deemed to be improper� The manufacturer ac-
cepts no liability for damages resulting from this�
In these cases the user/operator will bear the
sole risk�
WARNING
The sterilisation of liquids can cause
a risk of explosion, risk of burns,
boiling retardation and vapours that
are hazardous to health.
iDo not sterilise liquids in the unit�
WARNING
Risk of explosion due to ignition of
combustible materials
iDo not operate the unit in any rooms
in which inflammable mixtures may be
present, e�g� in operating theatres�
EN

6046100064L02 1702V002SE 5
Important information
2.10 Disposal
Unit
The unit may be contaminated� Instruct
the company disposing of the waste to
take the relevant safety precautions in
this case�
iDecontaminate potentially contaminated parts
before disposing of them�
iUncontaminated parts (e�g� electronics, plastic
and metal parts etc�) should be disposed of in
accordance with the local waste disposal reg-
ulations�
iIf you have any questions concerning the cor-
rect disposal of parts, please contact your
dental trade supplier�
Decontamination of potentially contaminated
parts
The following parts of the device may be con-
taminated�
– 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:
iEmpty the water containers�
iRemove all fixed connections for fresh water
and waste water�
iWipe-disinfect the inner surfaces of the water
containers with a surface disinfectant, e�g�
FD322 or FD333 from Dürr Dental�
iOnce the inner surfaces of the water contain-
ers have dried off, fill the fresh water container
with demineralized fresh water (see "7�7 Con-
necting the unit")�
iRun 2-3 cycles of the quick program�
iEmpty the water containers and wipe-disinfect
them�
2.6 Qualified personnel
Operation
Persons who operate the units must ensure safe
and correct handling based on their training and
knowledge�
iInstruct or have every user instructed in han-
dling the unit�
iRegularly train all operators who are responsi-
ble for use and maintenance of the device� As
part of this, the operators must also demon-
strate that they have understood everything
covered� Attendance lists of the training
course participants must also be kept�
Installation and repairs
iInstallation, readjustments, alterations, up-
grades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental�
2.7 Protection from electric shock
iWhen working on the units observe all the
relevant electrical safety regulations�
iImmediately replace any damaged cables or
plugs�
2.8 Only use genuine parts
iOnly use Dürr Dental parts or accessories and
special accessories specifically approved by
Dürr Dental�
iOnly use only genuine working parts and
spare parts�
2.9 Transport and packaging
The original packaging provides optimum pro-
tection for the device during transport�
If required, original packaging for the unit can be
ordered from Dürr Dental�
Dürr Dental does not accept any respon-
sibility or liability for damage occurring
during transport due to the use of incor-
rect packaging, even where the unit is
still under guarantee�
iOnly transport the device in its original pack-
aging�
iKeep the packing materials out of the reach of
children�
EN

6 6046100064L02 1702V002SE
3 Overview
1
2
3
4
8
9
5
6
7
10
11
12
1 Steam steriliser Hygoclave 90
2 Sterile air filter
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 magnet bracket
Product description
EN

6046100064L02 1702V002SE 7
Product description
3.5 Wear parts and spare parts
The following working parts need to be changed
at regular intervals (refer to the "Maintenance"
section):
Sterile air filter � � � � � � � � � � � � � � � � 6046-000-14
Door seal � � � � � � � � � � � � � � � � � � � 6046100080
Tray handle � � � � � � � � � � � � � � � � � � 6046100102
Stylus with magnet bracket � � � � � � 6046100129
Water filter set� � � � � � � � � � � � � � � � 6046100132
Drain hose for manual emptying of
fresh and waste water on the fore side
of the device � � � � � � � � � � � � � � � � � 6046100105
Water drain hose for "automatic water
discharge" on the rear side of the de-
vice� � � � � � � � � � � � � � � � � � � � � � � � 6046100128
Lubricant � � � � � � � � � � � � � � � � � � � 9000474001
Information on spare parts can be found
on the website portal for authorised spe-
cialist dealers under:
www�duerrdental�net�
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 magnet bracket
– 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
– Sterile air filter
– Hygotest, starter kit
– Network cable
– Mains cable
– Software "Tyscor Pulse"
– Installation and operating instructions
– Handover and installation record
3.2 Accessories
The following articles are necessary for the op-
eration of the unit, depending on the applica-
tion:
Tray (perforated) � � � � � � � � � � � � � � 6046100112
3.3 Special accessories
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
3.4 Disposable materials
The following materials are consumed during
operation of the device and must be ordered
separately:
Hygotest (Helix test bodies
with test strips) � � � � � � � � � � � � � � � 6050-600-03
EN

8 6046100064L02 1702V002SE
Product description
4 Technical data
Electrical data for the unit
Nominal voltage V AC 230
Electrical frequency Hz 50
Rated power W2600
Standby consumption W 1
Fuses 2 x T 12 AH / 250 V~ (IEC 60127)
Over-voltage category II
General technical data of device
Dimensions (H x W x D) cm 48 x 57�5 x 54
Weight, empty kg 65
Other technical data
Heat output at 23°C MJ/h 6�5
Noise level * dB(A) <65
Operating mode Continuous operation
Capacity of fresh water container lapprox� 4
Capacity of waste water container lapprox� 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 (in acc� with
IEC 60529) IP 20
Degree of soiling (in accordance with EN
61010-1) 2
* In accordance with EN ISO 1680 Airborne Noise Emissions; measured in a sound-insulated room�
Technical data for the sterilisation chamber
Internal dimensions, useable volume (∅x
D) cm 26 x 35
Volume l19
Load capacity (unpackaged instruments)
Bulky hollow instruments
Porous materials
kg
kg
6
2
Sterilisation temperature in acc� with DIN
EN 13060 °C 134 + 3
Heat-up time, at room temperature min approx� 15
Sterilisation hold time, program-depend-
ent min 3�5 - 20�5
Drying time, program-dependent min 10�5 - 16
Classification
Medical Devices Directive (93/42/EEC)
Manufacturer: Dürr Dental
Class IIb
(based on rule 15)
EN