parkell Integra D680 Manual

Caution: Federal Law restricts this device to sale by or on the order of a properly licensed practitioner.
Integra
™
Ultrasonic Tooth Scaler
Model D680
Device Description:
The Integra is an autotune ultrasonic tooth
scaler that operates at either 25KHz or
30KHz. The Integra automatically detects
whether the handpiece contains a 25KHz
or 30KHz insert, and switches operating
frequency to match. A dramatically
expanded low-power range improves
comfort during debridement.
Intended use/indications:
For removal of calculus and plaque during
dental prophylaxis.
Contraindications:
Not for use if the patient or operator is
wearing a pacemaker, or any other internal
electronic device.
Precautions:
Caution: Water fl ow during use must be
suffi cient to cool handpiece and insert.
Do not run this device dry.
IMPORTANT: The water supply line to
the scaler should always be turned off
whenever the device is being connected,
disconnected, or when not in use.
Caution: Do not allow prolonged contact
of tip with lips, cheeks, tongue or other
soft tissues.
Caution: Take precautions to prevent
transmission of contagious diseases from
ultrasonic aerosols.
Caution: Use the sides of the tip to remove
deposits from the tooth. Do not gouge the
tooth with the point.
Caution: Precautions should be taken to
guard against entrance of water from any
source into the transformer. The
transformer should be located away
from any source of water.
Individualization of treatment:
• If patient or operator is pregnant, consult
physician concerning advisability of using
ultrasonic scalers.
• Like all scalers of this type, the handpiece
produces a small magnetic fi eld. It has
been reported that this can cause some
sensitive patient monitoring devices such
as pulse oximeters to give inconsistent or
inaccurate readings.
Conformance to Standards:
The Parkell Integra conforms to
IEC60601-1 and CAN/CSA C22.2
No. 601.1. The device is CE marked—
certifi ed to European Medical Device
Directive (93/42/EEC). Parkell's quality
system is certifi ed to ISO9001/13485.
Included in your unit are:
• 1-Scaler Unit with an attached handpiece,
and 2-autoclavable handpiece sheaths
• 2-fl uid bottles, 1-water line with male
quick-connect coupler, and 1-detachable
foot controller
• 2-In-line Water Filters (Stock No. D419)
• 1-Transformer with cable
(Stock No. D408-120V, D403-230V)
• Instructions and Warranty registration card.