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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 relative
to the root apex.
This product must only be used in hospital environments, clinics or dental offices by
qualified dental personnel.
2. Warnings
Read all instructions before operating this unit. The manufacturer accepts no liability
for any damage resulting from improper use of this unit and/or for any purpose other
than those covered by these instructions.
U.S.A. Only:
US Federal law restricts this unit to sale by or on the order of a dentist.
As per Endodontic Standards of Care, always use a rubber dam when performing
endodontic treatment.
Do not use this unit with patients who have a pacemaker, as its effect has not been
evaluated.
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 122ºF).
Verify the measurements with a file and radiograph as abnormal canal anatomy or
unusual canal morphology may cause inaccurate measurements (i.e. blocked canals,
immature teeth).
Do not use damaged file clips or any accessory because an inaccurate measurement
could result.
Do not use dry heat sterilization on the file clips and touch probes.
The LCD screen readings 2.0, 1.75, 1.5, 1.25, 1.0, 0.75, 0.5 and 0.25 do not
correspond to any actual distance in mm. They serve as a convenient reference to
estimate the file tip position in relation to the apical foramen.
NOTE: Sometimes the
RomiApex™ A-15 reading and the x-ray image will not
correspond. This can be due to the actual location of the apical foramen and inaccuracies
of the x-ray angulation made before and during endodontic treatment.