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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
Intended use (FDA)
Indications for use
The intraoral sensor is intended to convert X-ray
photons into electronic impulses that may be
stored, viewed and manipulated for diagnostic
use by dentists.
Intended use (FDA)
The intraoral sensor is used to generate intraoral
X-ray images in conjunction with an intraoral X-
ray unit. Hygienic protective covers must be
used.
Only those accessories or parts specifically men-
tioned in the Installation and Operating Instruc-
tions may be used with the device.
The device must only be cleaned and disinfected
using the disinfectants and cleaning agents that
are listed in the Installation an Operating Instruc-
tions.
Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damage resulting from
improper usage. In such cases, the user/operator
will bear the sole risk.
The intraoral sensor is not suitable for monitoring
patients over a long-term period.
2121100020L29 2101V007
Important information
2.2
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: 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.
Units for commercial use may not be oper-
ated or used by:
– People lacking the necessary experience and
knowledge
– People with reduced physical, sensory or men-
tal capabilities
– Children
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.
2.4
Protection from electric
shock
Working on the unit, comply with all the rele-
❯
vant electrical safety regulations.
Never touch the patient and unshielded plug
❯
connections or metallic parts of the device at
the same time.
EN-
US
5
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