Rev. 05
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Page 3 of 12
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09/10
1.
Indications for use
•
RomiApex™ A-15
is an electronic device used for apex localization and working
length determination during root canal treatment.
•
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal
treatment, which requires precise determination of position of the dental file in the
canal relatively to the root apex
•
This product must only be used in hospital environments, clinics or dental offices by
qualified dental personnel.
2. Precautions
RomiApex™ A-15
was not tested on patients with implanted electro-medical devices
(pacemakers, etc.). Use of
RomiApex™ A-15
on patients or by personnel with such
devices should be avoided.
Do not use
RomiApex™ A-15
near devices emitting electromagnetic noise such as
fluorescent lamps, film viewers, ultrasonic devices, etc. Cellular phones, remote controls or
other devices generating electromagnetic waves may cause abnormal operation of
RomiApex™ A-15
. Such devices should be turned off.
•
RomiAPEX™ A-15 should not be used in the presence of flammable anesthetic
mixtures with air or with oxygen or nitrous oxide.
•
RomiAPEX™ A-15 must be stored in a dry place at temperatures b10°C
and 50°C (50ºF and 104ºF).
•
Caution: Federal law restricts this device to sale by or on the order of a physician or
licensed dental practitioner.
3.
Adverse Reactions:
None.
4. Package
Contents
Check the contents of the package before use:
●
1
RomiApex™ A-15
apex locator
●
1 Cradle
●
1
AAA
1.5V alkaline
battery
●
1 Measurement cable
●
2 File clips
●
5 Lip clips
●
1 Touch Probe
●
1 Screwdriver (for battery compartment)
●
1 User Manual