2
Safety
The unit has been developed and designed
appropriately such that hazards are largely
excluded if the unit is used in accordance with its
Normal Use.
Therefore, please note the following.
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 the
skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1
Unauthorised modification
Pursuant to Part 15.21 of the FCC rules, any
changes or modifications to this equipment not
expressly approved by Dürr Dental may cause,
harmful interference and void the FCC authoriza-
tion to operate this equipment.
2.2
CE-Certification
ScanX Edge
Intended purpose (CE)
The ScanX Edge is intended to be used for scan-
ning and processing digital images exposed on
Phosphor Storage Plates (PSPs) in dental appli-
cations.
Intended use (CE)
The unit may only be operated with accessories
and optional articles specified or approved by Air
Techniques.
The unit may be cleaned only with the disinfec-
tants and cleaning agents specified or approved
by Air Techniques.
Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damages resulting from
improper usage. The user bears the sole risk.
This unit is not suitable for monitoring patients
over longer periods of time. This unit must not be
operated in operating theatres or similar rooms,
in which dangers may arise from the combustion
of flammable materials.
Barrier envelope
Intended purpose (CE)
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Indication for use
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
2.3
FDA-Registration
ScanX Edge
Intended use
The ScanX Edge is intended to be used for scan-
ning and processing digital images exposed on
Phosphor Storage Plates (PSPs) in dental appli-
cations.
Contraindication
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damage resulting from
improper usage. The user bears the sole risk.
This unit is not suitable for monitoring patients
over longer periods of time. This unit must not be
used in operating rooms, in which hazards may
arise from the combustion of flammable materi-
als.
Barrier envelope
Intended use (FDA)
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Indication for use
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Contraindication
This Device has no contraindications.
Important information
2160100287L41 1911V006
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