2.7 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.
2.8 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.
The following accessories can have an effect on
the electromagnetic compatibility:
Mains cable
. . . . . . . . . . . . . . . . . . . 9000100846
Flexible foot switch cable . . . . . . 9000-119-130E
NOTICE
Negative effects on the EMC due to
non-authorised accessories
❯
Use only Dürr Dental parts or accesso-
ries specifically approved by Dürr Den-
tal.
❯
Using any other accessories may result
in increased electromagnetic interfer-
ence emissions or the unit having
reduced electromagnetic immunity,
leading to an erroneous operation
mode.
2.9 Essential performance char-
acteristics
The unit does not have any essential perform-
ance characteristics as set out in IEC 60601-1
section 4.3.
2.10 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.
2.11 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.
DÜRR MEDICAL accepts no liability for
damages or injury resulting from the use
of non-approved accessories or optional
accessories, or from the use of non-origi-
nal wear parts or replacement parts.
The use of non-approved accessories,
optional accessories or non-genuine wear
parts / replacement parts (e.g. mains
cables) can have a negative effect in
terms of electrical safety and EMC.
Important information
6 9000-615-32/02 2012V003
EN
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