Durr Dental Hygoclave 90, Installation And Operating Instructions Manual

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Important information
NOTICE
Damage to the unit or to the items
being sterilised due to unsuitable
materials
i
Only sterilise instruments, packaging
and textiles that are suitable for steam
sterilisation according to the manufac-
turer's information�
2.4 General safety information
i
When operating this device always observe all
guidelines, laws, and other rules and regula-
tions that are applicable at the site of opera-
tion�
i
Prior to each use, check condition of the de-
vice and make sure it is in perfect working
order�
i
Do not convert or modify the units�
i
Observe the Installation and Operating
Instructions�
i
Make 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.
i
Do not sterilise liquids in the unit�
WARNING
Risk of explosion due to ignition of
combustible materials
i
Do not operate the unit in any rooms
in which inflammable mixtures may be
present, e�g� in operating theatres�
EN