Air Techniques ScanX Swift View Installation And Operating Instructions Manual page 9

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 View
Indications for use
The ScanX Swift View is intended to be used for
scanning and processing digital images exposed
on Phosphor Storage Plates (PSPs) in dental
applications.
Contraindications
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 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. The touch screen only
shows a preview as an initial 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 diagno-
sis.
2142100008L41 2202V007
Important information
Barrier envelope
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.
2.3 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: By virtue of Federal Law, the
device may only be sold to dentists or
bought on behalf of a dentist.
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.
2.4 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.
Installation and repairs
All installation, resetting, alteration, expansion,
❯
and repair work must be carried out either by
Air Techniques personnel or by a suitably quali-
fied person approved by Air Techniques.
2.5 Protection from electric
shock
Comply with all relevant electrical safety regula-
❯
tions when you work with this unit.
EN-
US
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