parkell D680 Instruction Manual

DEVICE DESCRIPTION
The Parkell Integra™ is a magnetostrictive, auto­tuning, ultrasonic tooth scaler that operates at either 25 KHz or 30 KHz. It has an integrated, two-bottle, pump-driven fluid supply, and is also capable of obtaining fluid from an external water supply. The Integra automatically detects whether the handpiece contains a 25 KHz or 30 KHz insert, and switches to the correct operating frequency. The Integra has an expanded low-power range to improve patient comfort, and a power-boosting, user-controlled TURBO feature to increase scaling power when needed for heavy deposits.
INTENDED USE/INDICATIONS
For removal of calculus, plaque and oral debris from teeth during dental prophylaxis/scaling.
CONTRAINDICATIONS TO USE
Because of the potential for electromagnetic interference, this device should not be used on patients or by clinicians with cardiac pacemakers, internal defibrillators, intracorporeal fluid pumps or any other implantable electronic devices, or in close proximity to sensitive patient monitoring devices such as pulse oximeters.
IMPORTANT INFORMATION REGARD­ING USE OF NON-PARKELL INSERTS:
Parkell ultrasonic scalers are compatible with most major brands of ultrasonic inserts. For optimal performance of your scaler and insert, we recommend using Parkell ultrasonic inserts. Parkell cannot guarantee that all non-Parkell inserts available on the market today or in the future will work properly with our scalers. For more information, contact Parkell.
WARNINGS
• The water supply to the scaler should always be turned off whenever the device is being connected, disconnected, or when not in use.
• Do not run this device dry. Water must always flow through tip during use to cool handpiece and insert.
• The power supply line cord functions as the AC power disconnect device for the scaler.
• The transformer should be located above and away from any sources of water. As with all electrical devices, the unit should not be immersed in water or other liquids. Do not reach for the device if it has fallen into liquid until power is disconnected, and do not use the device after it has fallen into liquid. Return the device to Parkell for servicing.
• Modification of this device will void the warranty, and may violate safety codes, endangering the patient and/or the clinician.
• This equipment is not suitable for use in the presence of a flammable anesthetic gas mixture (when used along with air or oxygen).
• This equipment produces electromagnetic energy and may cause interference with other nearby electronic devices. Should this occur, changing the position or location of the device may be necessary.
INSTRUCTIONS FOR USE
STOCK NO. D680
24-HOUR SAFETY HOTLINE
1-800-535-5053
CAUTION: RX ONLY
This manual, in whole or in part, should not be considered a substitute for formal training in Ultrasonic Scaling.
Appropriate professional education is STRONGLY RECOMMENDED prior to using this device clinically.
ULTRASONIC SCALER
Shown with Parkell’s Burnett
Power-Tip Insert (not included)
A00545revC0317
Easy-to-clean touch panel resists all
standard disinfectants
Digital fluid and power
controls mean fast, precise settings (Use the Smart Foot Pedal for hands-free power
adjustment.)
Automatically adjusts operating
frequency to match either 25KHz
or 30KHz inserts
Autoclavable
handpiece
sheaths
Handpiece-holder
mounts on left or right
CLINICAL PRECAUTIONS
• Protect patient’s eyes, lips, cheeks, tongue or other vulnerable tissues from contact with the vibrating scaler tip.
• Protect the patient’s clothing from water damage when using this device.
• Clinicians should wear eye protection and facemask when using this device.
• Keep the long axis of the insert tip parallel to the long axis of the tooth while maintaining gentle contact with the root to “wipe” deposits from the tooth. Prolonged perpendicular contact between the insert tip and the tooth will damage the tooth by gouging it.
INDIVIDUALIZATION OF TREATMENT
If patient or operator is pregnant, or has any medical condition which might be affected by this device during treatment, consult a physician prior to use.
THE INTEGRA IS SUPPLIED WITH:
(1) Magnetostrictive Scaler Control Unit with
integrated, pump-driven, two-bottle water supply, attached handpiece, foot controller and water line (with male quick-connect coupler).
(1) Detachable Foot Controller.
(2) Autoclavable handpiece sheaths (one attached)
(Stock No. D576).
(2) Fluid Bottles with screw-on caps.
(1) Bottle Lock.
(2) Inline water filters (one attached to water line)
(Stock No. D419).
(1) Transformer with cable (Stock No. D408/GS257-
120V, D403/GS438-230V).
(1) Instructions for Use
INSERTS
Magnetostrictive inserts for the Integra scaler are available separately, and are not included with the basic scaler unit. However, they may be included in a scaler package that you have chosen to purchase. Parkell scalers are compatible with most major brands of 25 KHz or 30 KHz magnetostrictive ultrasonic inserts. For optimal performance of your scaler and insert, we recommend using Parkell ultrasonic inserts. Parkell cannot guarantee that all non-Parkell inserts available on the market today or in the future will work properly with our scalers. For more information, contact Parkell.
The scaler automatically adjusts the operating frequency to match that of the insert in the handpiece without operator intervention. Brand new inserts may initially fit tightly in the handpiece, and may be inserted and removed more easily by using a slight twisting motion, or by lubricating the insert “O” ring with water. Old, worn or blunt inserts will scale poorly and generate excess heat, and should be replaced when necessary.
SPECIFICATIONS
• Operating frequencies – 25KHz and 30KHz.
Operating temperature – between 50°F (10°C) and 95°F (35°C).
Operates at relative humidity of 10-80% (non-condensing).
• Weight: 35 oz. / Dimensions: 5” W x 6” H x 11.5” D.
Power: 120VAC model - 60 Hz, 120VA / 230VAC model ­50 Hz, 120VA / 100 VAC model – 50/60 Hz, 120VA.
• Transport and storage conditions: 10-40°C, 10-80% RH (non-condensing).
ADDITIONAL SPECIFICATIONS
• Protection against electric shock: Class 1, Type B applied part.
• Protection Against Ingress of Liquids
1. Foot Switch & Scaler - IPX1 (drip-proof).
2. Power Supply - IPX0 (ordinary).
• Mode of operation of equipment: Intermittent – 66% duty cycle, 10 minutes on, 5 minutes off.
2
I
INSTALLING THE SCALER
Locate the device where the control panel will be easy to reach during scaling procedures, and where the water filter at the rear of the unit may be periodically changed without difficulty. The scaler requires access to a grounded electrical outlet and an optional connection to a source of drinking-quality water from the building water supply. Alternatively, the unit may receive fluid exclusively from the internal bottle supply
WATER CONNECTION
If the clinician chooses to operate the Integra on city water, before plugging in the device, they should connect the scaler’s water line through the included filter disk to a drinking-quality water supply (15-35 psi optimal), free of sediment, at room temperature. An external, office-wide water filter is recommended to minimize frequent changes of the device’s in-line water filter. The male quick-connect that comes on the end of the water hose is the standard fitting presently used in the dental industry. If you are replacing a scaler that uses an Adec-type or other type of connection, remove the old fitting from the unit hose and attach it to the new water line. Check for leaks at all hose and filter connections before use, and tighten if necessary.
USING THE INTERNAL FLUID SUPPLY BOTTLES
The Parkell Integra is equipped with two internal bottles which can supply the fluid that flows through the handpiece for cooling and lavage during use. The bottles may be filled with drinking-quality water, or diluted with anti-microbials at a ratio of 4 parts water to 1 part chlorhexidine or mouthwash. If fluids other than water are used in the bottles, the system should be flushed with plain water after each use.
To fill the bottles:
1. Open the Integra cover. You will see two bottles, with the bottle-lock holding them in place.
2. Using finger and thumb, gently squeeze the two retaining lugs of the bottle-lock and remove it from the unit.
3. Remove the bottles from the unit. Unscrew and remove the caps from them.
4. Fill the bottles up to the fill line marked on the side.
5. Replace the caps on the bottles, making sure they are screwed on all the way.
6. Replace the bottles in the rear of the Integra, making sure they are standing upright in the base of the unit.
7. Replace the bottle-lock over the bottles. Look for the word “Top” on the bottle-lock to make sure it is in correctly. As before, using finger and thumb, squeeze the two retaining lugs and gently press the bottle-lock down. Release the lugs. They should locate into the side of the clear cover and hold the bottles firmly in place.
8. Completely close the Integra lid. If not fully closed, the unit will not be able to draw fluid from the bottles.
9. Monitor the fluid level in the bottles regularly during use and refill as required. A constant fluid flow is necessary for correct operation of the Integra during scaling.
Foot Pedal
Power
External water
flow regulator
External water
connection
3
Bottle-Lock
(DO NOT DISCARD)
Apply lubricant to both ‘O’ rings.
The lid must be closed completely for the unit to function correctly with the internal fluid system. If the lid does not close completely or it sticks, then the t wo black ‘O’ rings on the underside of the cover may be dry and require a little lubrication. Apply a very thin layer of Vaseline to each ‘O’ ring with a Q-Tip. Just a thin layer is all that is necessary.
IMPORTANT:
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