Copyright Information; Safety; Unauthorized Modification; Intended Use (Fda) - Air Techniques ScanX Swift 2.0 Installation And Operating Instructions Manual

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Important information
Non-ionizing electro-magnetic radiation
Warning – risk of dangerous electric vol-
tages
Warning - laser beams
This way up / store and transport in an
upright position
Keep dry
Stacking limits
n
xx %
Lower and upper humidity limits
xx %
YY
Lower and upper temperature limits
XX
Lower and upper atmospheric pressure
YY
limits
XX
Fragile, handle with care
Keep away from sunlight during storage
1.2

Copyright information

All electronic drawings, processes, names, soft-
ware, and appliances mentioned here are pro-
tected under copyright.
Printing or copying these Installation and Operat-
ing Instructions, including excerpts thereof, may
only be carried out with the written approval of
Air Techniques.
4
|
EN-US
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
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

Unauthorized modification

Pursuant to Part 15.21 of the FCC rules, any
changes or modifications to this equipment not
expressly approved by the manufacturer may
cause, harmful interference and void the FCC
authorization to operate this equipment.
2.2

Intended use (FDA)

ScanX Swift 2.0 - XPS07.1A...
Indications for use
The ScanX Swift 2.0 is intended to be used for
scanning and processing digital images exposed
on Phosphor Storage Plates (PSPs) in dental
applications.
Barrier envelope
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.
2.3

General safety information

The sale or prescription of this device by a
medical 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: By virtue of Federal Law, the
device may only be sold to dentists or
bought on behalf of a dentist.
2144100140L29
G8802
2310V007

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