Safety; Intended Use (Fda); General Safety Information; Specialist Personnel - Air Techniques ScanX Intraoral View Instrucciones De Uso

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Safety

The unit has been developed and designed appropriately such that hazards are largely
excluded if the unit is used in accordance with its
Intended 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

Intended use (FDA)

ScanX Intraoral View / ScanX Classic View
Indications for use
The ScanX Intraoral View is intended to be used
for scanning and processing digital images
exposed on Phosphor Storage Plates (PSPs) in
dental applications.
The ScanX Classic View is intended to be used
for scanning and processing digital images
exposed on Phosphor Storage Plates (PSPs) in
dental applications.
Intended use
The ScanX Intraoral View is intended to be used
for scanning and processing digital images
exposed on Phosphor Storage Plates (PSPs) in
dental applications.
The ScanX Classic View is intended to be used
for scanning and processing digital images
exposed on Phosphor Storage Plates (PSPs) in
dental applications.
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.
The unit is not designed for operation within the
patient environment.
This unit is not suitable for monitoring patients
over extended periods of time.
This unit must not be used in operating rooms or
similar rooms, in which hazards may arise from
the combustion of flammable materials.
2151100018L40 2012V016
Important information
The touch screen only shows a preview as an ini-
tial impression of the X-ray image. For purposes
of diagnosis, the X-ray image must be viewed on
a diagnostic monitor. The preview of the X-ray
image on the touch screen is not suitable for the
purposes of diagnosis.
Barrier envelope
Intended use (FDA)
Disposable Barrier Envelopes are intended to be
used as a disposable barrier for Air Techniques
Phosphor Storage Plates. This device is non-
sterile and intended for single patient use only.
Indication for use
Disposable Barrier Envelopes are intended to be
used as a disposable barrier for Air Techniques
Phosphor Storage Plates. This device is non-
sterile and intended for single patient use only.
Contraindication
This Device has no contraindications.
2.2

General safety information

The sale or prescription of this device by a medi-
cal practitioner is subject to the restrictions of the
applicable Federal Acts. The device may be used
only under permanent supervision by a dentist or
licensed medical practitioner.
Caution: Federal law restricts this device
to sale by or on the order of a Doctor.
Comply with the guidelines, laws, rules and
❯
regulations applicable at the site of operation
when you use this unit.
Prior to each use, check the function and
❯
proper condition of the device.
Do not convert or modify the unit.
❯
Comply with the Installation and Operating
❯
Instructions.
Make the Installation and Operating Instruc-
❯
tions always available to the operator in the
vicinity of the device.
2.3

Specialist personnel

Operation
Persons operating the unit must ensure safe and
correct handling based on their training and
knowledge.
Instruct or have every user instructed in han-
❯
dling the unit.
EN-
US
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