Product Overview; Technical Support; Supplies & Replacement Parts; Indications For Use - Cavitron touch Gebrauchsanweisung

CAUTION: United States Federal Law restricts this device to sale
by or on the order of, a licensed dental professional.
For dental use only.

PrOduCT OvErviEw

The Cavitron Touch™ Ultrasonic Scaling System offers an advanced
experience at your fingertips. The unit features a modern touch
screen interface for ease of use with added memory presets and
customizable power settings for improved efficiency. The system
also features a lightweight, detachable handpiece cord for improved
ergonomics.

TEChNiCAL SuPPOrT

For technical support and repair assistance in the U.S., call the
DENTSPLY Cavitron Care Factory Certified Service at 1-800-989-8826,
Monday through Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time). For
other areas, contact your local DENTSPLY® representative.
SuPPLiES & rEPLACEMENT
PArTS
To order supplies or replacement parts in the U.S., contact your
local DENTSPLY Distributor or call 1-800-989-8826, Monday through
Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time). For other areas, contact
your local DENTSPLY Representative.
SECTiON 1:

indications For use

USED FOR ULTRASONIC PROCEDURES:
• All general supra and subgingival scaling applications
• Periodontal debridement for all types of periodontal diseases
SECTiON 2:

Contraindications

• Ultrasonic Systems should not be used for restorative dental
procedures involving the condensation of amalgam.
• Not for use on children under the age of 3.
SECTiON 3:

warnings

• The use of High Volume Saliva Evacuation to reduce the quantity
of aerosols released during treatment is highly recommended.
• Prior to beginning treatment, patients should rinse with an
antimicrobial such as Chlorhexidine Gluconate 0.12%. Rinsing
with an antimicrobial reduces the chance of infection and reduces
the number of microorganisms released in the form of aerosols
during treatment.
• It is the responsibility of the Dental Healthcare Professional to
determine the appropriate uses of this product and to understand:
– the health of each patient,
– the dental procedures being undertaken,
– and applicable industry and governmental agency
recommendations for infection control in dental healthcare
settings,
– requirements, and regulations for safe practice of dentistry; and
– these Directions for Use in their entirety, including Section 4
Precautions, Section 6 Infection Control, and Section 10 System
Care.
• Where asepsis is required or deemed appropriate in the best
professional judgment of the Dental Healthcare Professional, this
product should not be used, unless used in combination with a
sterile lavage kit (P/N 81340).
• Handle Cavitron® insert with care. Improper handling of insert,
specifically the insert tip, may result in injury and/or cross
contamination.
• Failure to follow properly validated sterilization processes and
approved aseptic techniques for Cavitron inserts or handpieces
may result in cross contamination.
• Persons fitted with cardiac pacemakers, defibrillators and other
active implanted medical devices, have been cautioned that some
types of electronic equipment might interfere with the operation
of the device. Although no instance of interference has ever been
reported to DENTSPLY, we recommend that the handpiece and
cables be kept 6 to 9 inches (15 to 23 cm) away from any device
and their leads during use.
There are a variety of pacemakers and other medically
implanted devices on the market. Clinicians should contact
the device manufacturer or the patient's physician for specific
recommendations. This unit complies with IEC 60601 Medical
Device Standards.
• Insufficient water flow could result in elevated water and tip
temperature. When operated at the input water temperature
specified in the Water Line Requirements Section 7.1 and with
sufficient water flow, the water and tip temperature should
not exceed 50° C (122° F). Failure to follow recommendations
for environmental operating conditions, including input
water temperature, could result in injury to patients or users.
If temperature is elevated, increase water flow. If temperature
remains elevated, discontinue use.
• During boil-water advisories, this product should not be operated
as an open water system (e.g. connected to a public water system).
A Dental Healthcare Professional should disconnect the system
from the central water source. The Cavitron DualSelect™ system
can be attached to this unit and operated as a closed system
until the advisory is cancelled. When the advisory is cancelled,
flush all incoming waterlines from the public water system (e.g.
faucets, waterlines and dental equipment) in accordance with the
manufacturer's instructions for a minimum of 5 minutes.
• Per FCC Part 15.21, changes or modifications not expressly
approved by the party responsible for compliance could void the
user's authority to operate this equipment.
• This portable transmitter with its antenna complies with FCC/IC RF
exposure limits for general population / uncontrolled exposure.
• This Device complies with Industry Canada License-exempt RSS
standard(s). Operation is subject to the following two conditions:
1) this device may not cause interference, and 2) this device must
accept any interference, including interference that may cause
undesired operation of the device.
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