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INDICATIONS FOR USE
The cordless elements™ IC obturation system is intended to be used in Endodontics
to backfill and downpack gutta-percha during root canal obturation using warm
vertical obturation technique.
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 natural rubber latex or
copper.
WARNINGS
Read the following warning before using this device.
• This device has been investigated with regards 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 Kerr Endodontics if you have any further questions regarding
electrical safety or EMC.
• 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.
— Consult the manufacturer for help.
WARNING: This product can expose you to chemicals including Lead
and Lead Compounds, which are 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.
Treatment Procedure
• elements™ IC system can only be used with Kerr elements gutta-percha
cartridges and heat pluggers.
• The heat pluggers and elements gutta-percha cartridges are designed to
reach high temperatures. Inadvertent contact with patient and operator must
be avoided to prevent accidental burns.
• Do not touch the cartridge needle within one minute after the device is turned
off to avoid potential burn risk. Wait until the Backfill device is completely
cooled down before touching the cap.
• Handle empty elements gutta-percha cartridges by the plastic locknut only.
Other portions could be hot and could result in a serious burn.
Use, Repairs and Service
• For use by qualified and trained personnel only.
• U.S. federal law restricts the sale of this device by or on the order of a
healthcare professional.
• To reduce the risk of electrical shock, do not remove charging cover. Refer
servicing to qualified service personnel.
• Only use the specified Kerr Endodontics transformer and power cords.
• Use of other accessories that are not authorized for use in connection with this
device may cause malfunction and compromise patient safety.
• No modification of this equipment is allowed.
• When transporting the device, use the original packaging provided by
manufacturer to prevent accidental activation of the unit or any damage to
the device itself.
Replacing or Shipping the Battery
• Only use Kerr Endodontics batteries designated for this system. Use of other
batteries may damage the device(s) or cause a malfunction.
• Air or land transportation of the device is allowed if they are in the original
packaging container.
• For shipping batteries within the United States or Internationally, consult
the Department of Transportation's Pipeline and Hazardous Materials Safety
Administration or the International Air Transport Association guidelines.
077-0901_REVA_ELEMENTS_IC_EU_IFU_BOOK_P24.indb 3
PRECAUTIONS
• Do not use in teeth with immature and/or over instrumented root canal apices
unless the apex has been sealed.
• A protective dental dam is highly recommended when using this device.
• For the Backfill device, keep temperature setting above 150°C.
Extruding material at lower temperatures will create more stress on the motor,
and may shorten the device's life.
• Elements gutta-percha cartridges are for single-patient use.
• The electronic components should not be autoclaved as it will damage the
circuitry.
• Do not spray the devices with any liquids as it may damage the circuitry.
• Do not immerse the gutta-percha cartridges in any liquid and do not autoclave
them.
• Do not allow liquids to collect in the Charging Base or come in contact with the
connector as it may damage the circuitry.
• Do not allow liquids to enter the openings for the heat plugger on the
Downpack device or the elements gutta-percha cartridge on the Backfill device
as it may damage the circuitry.
• Avoid multiple activations of the Downpack device while operating
inside the root canal since prolonged exposure to the high temperatures may
cause damage to the tissues surrounding the tooth (PDL or bone).
ADVERSE REACTIONS
None known.
SYMBOLS
Serial Number
Manufacturer
Manufacturing Date
Authorized Representative in the European Community
Corresponds to MDD 93/42 EEC Including
EN 60601-1 and EN 60601-1-2
This Way Up
CSA Mark with "C/US" Indicator for Certified Products
Precaution/Warning
Fragile, Handle with Care
Stack 12 Maximum
Keep Dry
Type B Applied Part
Temperature Limits for Storage and Transportation
Do Not Autoclave
Humidity Limitation
Do Not Throw into Trash
Pressure Limitation
Part Number
Consult Accompanying Documents
CAUTION: Federal law restricts this device to sale by or on the
order of a dentist
Protected against vertically falling water drops when
enclosure tilted up to 15°. Applies to Backfill and Downpack
devices
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6/13/19 6:21 PM
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