– Use for separation of dust, sludge or plaster or
similar substances.
– Use in conjunction with flammable or explosive
mixtures.
– Installation in a manner that does not comply
with the installation instructions, in particular
set-up in rooms containing a potentially explo-
sive atmosphere.
– Cleaning and disinfection with agents contain-
ing sodium hypochlorite or potassium hypo-
chlorite.
2.4 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.
2.5 Combining devices safely
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.
2.6 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.
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.
2.7 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.
2.8 Electrical safety
❯
Comply with all the relevant electrical safety
regulations when working on the unit.
❯
Never touch the patient and unshielded plug
connections on the device at the same time.
❯
Replace any damaged cables or plugs immedi-
ately.
Observe the EMC rules concerning medical
devices
❯
The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the appliance is operated in
another environment, potential effects on elec-
tromagnetic compatibility must be taken into
account.
❯
Do not operate the unit in the vicinity of HF sur-
gical instruments or MRT equipment.
❯
Maintain a minimum distance of at least 30 cm
between the unit and other electronic devices.
❯
Keep a minimum distance of 30 cm between
the unit and mobile radio devices.
❯
Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
Important information
9000-606-44/30 2011V003 5
EN
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