Device Description; Indications For Use; Contraindications; Adverse Reactions - SybronEndo elements obturation unit Bedienungsanleitung

DEVICE DESCRIPTION

The elements obturation unit combines the System B
TM
loaded, backfill extruder. The System B Handpiece provides heating of the Heat Plugger with
precision controlled temperature and timing. The Backfill Extruder features single-use standard
elements TM Gutta Percha Cartridges. The Obturation Unit's motorized system extrudes gutta percha
under precise temperature and speed control.

INDICATIONS FOR USE

The elements obturation unit is intended to be used in dentistry to provide continuous heat at
TM
the tip of a dental instrument to backfill and downpack gutta percha during endodontic root canal
treatment.
Additionally, when the unit is used in the Extruder Mode, the elements
only to backfill gutta percha during root canal obturation.

CONTRAINDICATIONS

• Not for use in the presence of flammable anesthetics such as a mixture of oxygen, air and
nitrous oxide.
• The obturation unit should NOT be used on a patient with a pacemaker.
• Do not use on patients with a known sensitivity to copper and rubber latex.
• When using natural rubber latex gutta percha with this device, please check if patient is
sensitive/allergic to natural rubber latex. Note: SybronEndo gutta percha is not made with
natural rubber latex.
WARNINGS
• The System B tips and elements Gutta Percha cartridges are intended to reach high
TM
temperatures. Inadvertent contact with patient and operator must be avoided to prevent
accidental burns..
• When replacing the extruder cartridge during a procedure, the cartridge may be hot to the
touch. Handle empty extruder cartridge by the plastic locknut only. Other portions could be hot
and could result in serious burns.
• Do not use the device near water. If unit is accidentally dropped in water, it might cause electric
shock, destroy the device and can lead to serious injury or death.
• Only use the specified SybronEndo AC power supply and power cords.
• Use of other accessories that are not authorized for use with this device may cause malfunction
and compromise patient safety.
• No modification of this equipment is allowed.
• For servicing refer to warranty information section.
WARNING: This product can expose you to chemicals including Lead and Lead
compounds, which is known to the State of California to cause cancer and birth defects or
other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
PRECAUTIONS
• A protective dental dam is highly recommended when using this device.
• elements Gutta Percha Cartridges are for single-patient use.
TM
• For use by qualified and trained personnel only.
• U.S. Federal law restricts this device to sale by or on the order of a healthcare professional.
• When not in use, remove main plug from wall socket to isolate unit from mains power.
• Do not use in teeth with immature and/or over instrumented root canal apices unless the apex
has been sealed.
• Avoid multiple activations of the System B handpiece while operating inside the root canal
since prolonged exposure to high temperatures may cause damage to the tissues surrounding
the tooth (PDL or bone).
• While using the device in Hot pulp test mode, place a small amount of a gutta percha pellet on
the hot pulp test tip prior to application to patient's tooth. The hot pulp test tip should not be
placed directly on the tooth surface.
• Do not sterilize the Heat Plugger in a chemical sterilization unit as it might corrode its
components.
Heat Source with the first cartridge-
TM
TM obturation unit is used
CAUTION: This device has been tested and found to comply with EMC limits for the
Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The device
generates radio frequency energy and, if not installed and used in accordance with
these instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular
installation. If this device does cause harmful interference with other devices, which
can be determined by turning the device off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between devices.
• Connect the device into an outlet on a circuit different from that to which the other
device(s) is connected.
• For help with installation and configuration of the device contact Customer Service.
CAUTION: This device has been investigated with regard to safety from electrical shock
and fire hazard as well as electromagnetic compatibility (EMC). The device has not been
investigated for other physiological effects. Please contact SybronEndo if you have any
further questions regarding electrical safety or EMC.

ADVERSE REACTIONS

None known.
STEP-BY-STEP INSTRUCTIONS
INITIAL SETUP
1. Plug the Extruder handpiece cord into the appropriate electrical connector on the right front
panel of the unit by lining up the red dotted markings.
2. Plug the System B handpiece cord into the appropriate electrical connector on the left front
panel of the unit by lining up the red dotted markings.
3. Plug the correct cord for your country's power into the elements
4. Plug the power cord into wall power.
5. Plug the power supply into the back of the unit.
POWERING UNIT ON
Power the unit ON by pushing the
for 2 seconds.
INSTALLING/REMOVING SYSTEM B AND EXTRUDER HANDPIECE SHIELDS
To install the System B or Extruder Handpiece Shield line up the index markings and carefully slide
the shield onto the handpiece until a "click" is felt and heard. To remove the System B or Extruder
Handpiece Shield, hold the bottom part of the handpiece with one hand, use other hand to grab the
shield and pull away the handpiece shield without twisting.
4
Obturation Power Supply.
TM
button on the unit or the button on either of the handpieces