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
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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