Accessories; Product-Specific Safety Information; Patient Safety; Duty To Report Serious Incidents - Krömker UltraNeb Instrucciones De Uso

For your safety and the safety of your patients
3.4

Accessories

The manufacturer hereby declares that they are only
responsible for the safety, reliability and serviceability
of the device if original spare parts are used and if
device repairs are carried out exclusively by persons
who have been authorised by the manufacturer
to do so. The statutory warranty period applies. In
the event of warranty claims, please contact the
authorised dealer.
D WARNING!
Only the accessories listed in the order list have
been tested and approved for use with the medical
device. It is therefore strongly recommended that
the medical device be used in conjunction with these
accessories only. Otherwise the correct function of
the medical device may be at risk and no guarantee
is provided.
3.5

Product-specific safety information

D WARNING!
Danger of malfunction!
Unauthorised modifications of the medical device
result in malfunctions and may lead to dangerous
situations.
It is prohibited to modify this medical device without
the manufacturer's permission.
3.6

Patient safety

With the equipment of the medical device, the
associated documentation and the medical device
labels it is assumed that the medical device is
acquired and used exclusively by specialists and
that the basic functions of the medical device are
known to the user. The instructions for use as well
as the safety information marked WARNING and
ATTENTION are therefore essentially limited to the
special features of the medical device. This user
manual does not contain any information regarding
hazards that are obvious to professionals, the
consequences of incorrect use of the medical device
and possible negative effects on patients with various
underlying diseases.
96200-114 – 10 – 15.07.2020
3.7

Duty to report serious incidents

If serious incidents should occur in conjunction with
this device, the incidents must be reported to the
following bodies:
− The manufacturer.
− The authority responsible in the country in which
the incident took place.
3.8 Information regarding electromagnetic
compatibility
General information regarding electromagnetic
compatibility (EMC) in accordance with international
EMC standard IEC 60601-1¬2.
Medical electrical devices are subject to special
precautions regarding electromagnetic compatibility
(EMC) and must be installed and commissioned
according to the EMC information provided.
D „14. Electromagnetic compatibility" (Seite 55).
Portable and mobile high frequency communication
devices can affect medical electrical devices.
3.9

Checking the delivery

When the device is delivered, check that all
components are present and in faultless condition.
Take the device out of the packaging and first check
that the delivery matches with the order and that it
is complete.
D „11.1 Standard delivery (2010-41-0-000, Class IIa)"
(Seite 52).
In the event of complaints, please contact the
authorised dealer. Devices are not delivered sterile.
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