parkell Foramatron D645 Instructions For Use Manual

DEVICE DESCRIPTION:
A battery-powered, dental electronic device used to determine
the working length of a tooth's root canal(s) during endodontic
treatment. The Foramatron establishes a safe, low current, electrical
circuit through a tooth using an endodontic file or reamer, which is
monitored to calculate when the instrument's tip reaches the apical
foramen. The Foramatron uses LED lights and sound to indicate
when the apex is reached.
INDICATIONS / INTENDED USE:
The Foramatron is indicated for use as an aid in establishing the
working length of a root canal in a tooth that requires endodontic
treatment.
CONTRAINDICATIONS:
To function properly, this device requires that the tooth have an
intact periodontal ligament. Erroneous readings may be obtained if:
1) the periodontal ligament has been seriously damaged or
destroyed by periapical disease,
2) the tooth is ankylosed to the bone,
3) the apex is excessively open (as may be the case in primary
teeth or incomplete secondary teeth),
4) pre-operative radiographs indicate the presence of a well-
defined, long-standing, periapical radiolucency, a crack in the
tooth, internal or external resorption or excessively deep root
caries, or
5) a metal restoration cannot be bypassed and is interfering with the
apex locator's electronic signal.
WARNINGS: Because of the potential for electromagnetic
interference, this device should not be used on patients with
cardiac pacemakers, internal defibrillators, intracorporeal
fluid pumps or any other implantable electronic devices. Avoid
use in the vicinity of electrical surgery equipment, which may
interfere with readings.
Full EMC related information Emission/ immunity tables will be
available upon request.
Except for the battery compartment, do not open the case. There
are no user-serviceable parts inside. Opening the case will void all
warranties. Do not modify this device in any way. Modification could
violate safety codes and endanger patient and/or operator, and will
void all warranties.
This device is designed to be powered by a 9-volt alkaline battery
only. To reduce battery drain, if accidentally left on, the Foramatron
"goes to sleep" after approximately 20 minutes of non-use. To "wake
up" the device once it has "gone to sleep", turn it OFF and then
ON again. Even in "sleep mode", the unit drains a small amount of
current from the battery, so always turn off the unit at the end of the
procedure.
This manual is not a substitute for formal training in Endodontic Apex Location.
Rx Only
INSTRUCTIONS FOR USE
24-HOUR SAFETY HOTLINE
CONFORMANCE TO STANDARDS:
The Parkell Foramatron is TUV listed and conforms to IEC 60601-1,
60601-1-2 and CAN/CSA C22.2 No. 60601-1:2008. Parkell's quality
system is certified to ISO13485. The device is CE marked— certified
to European Medical Device Directive (93/42/EEC).
HOW SUPPLIED:
• Digital Foramatron Endodontic Apex Locator
(with 9-volt battery installed)
• Accessory Bag (Stock No. D611) containing:
1 - Instrument Cable (autoclavable)
2 - Red Instrument Clips (autoclavable) (Stock No. D619RH)
2 - Lip Contacts (autoclavable) (Stock No. D619GC)
1 - Green Self-Test/Calibration Plug
1 - Quick-Probe (autoclavable) (Stock No. D613)
1 - Plastic Insulation Sheath
• Operator's Manual/Instructions for Use
Replacement parts are available from Parkell Customer Service at
800-243-7446, or at www.parkell.com.
DIRECTIONS FOR USE:
The following suggested clinical technique may be modified by
experienced clinicians as needed.
1) Before each use, inspect the cables to be sure they are not
frayed, bent or that the insulation is not damaged.
2) Administer local anesthesia. Inadequate anesthesia may result in
patient discomfort.
3) Isolate the operative field with a rubber dam. Ensure that clamp
does not touch the Lip Contact (#13).
4) Remove all carious or undermined tooth tissue and obtain
appropriate access opening into the pulp chamber.
5) Extirpate the coronal pulp tissue completely from the pulp
chamber. Flush the chamber with an irrigant solution such
as water, hydrogen peroxide, sodium hypochlorite, EDTA,
anaesthetic solution or saline. For consistent, accurate readings,
the pulp chamber should be dried with a cotton pledget, while the
root canals should be left slightly moist with irrigant. Make sure
to control any pulpal bleeding which may refill the pulp chamber.
Dry the outer tooth surfaces with the air syringe.
6) Plug the Instrument Cable (#9) into the Foramatron via the
Instrument Cable Socket (#8) on the side of the unit. The
Instrument Cable plug is directional, so be sure that the round
side of the plug corresponds to the round side of the Socket.
7) Connect a Lip Contact (#13) to one of the open sockets at the
end of the Instrument Cable (#9). Drape the Lip Contact over
the lower lip, using a small amount of toothpaste on the Contact
to enhance conductivity. The metal Lip Contact may be bent if
desired.
STOCK NO. D645
1-800-535-5053
A00699revD0417
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