Parkell TurboSensor Ultrasonic Scaler

Device Description

The Parkell TurboSensor® is an autotune magnetostrictive ultrasonic tooth scaler that operates at either 25 KHz or 30 KHz. The TurboSensor automatically detects whether the handpiece contains a 25 KHz or 30 KHz insert, and switches to the correct operating frequency. The TurboSensor has an expanded low-power range to improve patient comfort during debridement, and a power-boosting, user-controlled Turbo feature to increase scaling power when needed for heavy deposits. The unit is designed to work with Parkell inserts.

Indications/Intended for Uses

For removal of calculus, plaque and oral debris from teeth during dental prophylaxis/scaling.

Contraindications

Due to 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.

If a 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.

In the event of any adverse reaction from the patient, discontinue the scaling procedure.

Warnings

• The water supply to the scaler should always be turned off whenever the device is being connected, disconnected, or when not in use.
• The power supply cord functions as the AC power disconnect device for the scaler.
• The transformer should be located above and away from any sources of water that may enter the unit. 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.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Clinical Precautions

• Protect patient's eyes, lips, cheek, tongue or other vulnerable soft tissues when using this device.
• Protect the patient's clothing from water damage when using this device.
• Clinicians should wear eye protection and face mask when using this device.
• Water flow through tip during use must be sufficient to cool handpiece and insert.
• Keep the long axis of the insert tip parallel to the long axis of the tooth to wipe deposits from the tooth.
• Do not gouge the tooth with the point of the tip.
• In the event that the patient experiences discomfort due to the sound and vibration from the scaling procedure, provide ear protection.
• Do not use the point of the insert on the tooth surface. You may gouge the tooth.
• Pause occasionally during scaling by removing foot from pedal to evaluate deposit removal.
• Exercise caution near ceramic restorations, as they can discolor or fracture if stressed.

Common Operator Errors That May Result in Poor Clinical Performance

• Failure to keep insert tip parallel to the long axis of the tooth.
• Excessive use of hand pressure.
• Failure to use the lowest effective power setting for the case at hand.
• Insufficient water flow.
• Scaling with the point of the insert instead of the side.
• Inserts that are damaged, bent or worn out.

Cleaning and Infection Control

• Consult www.CDC.gov for the "Guidelines for Infection Control in Dental Health-Care Settings" and "Statement on Reprocessing Dental Handpieces".
• DO NOT AUTOCLAVE the TurboSensor control unit, as autoclave heat will destroy it. The control unit should be cleaned of debris with a water-damp paper towel, disinfected by wiping with a paper towel that has been saturated with an EPA-registered low-level (HIV/HBV claim) to intermediate-level (tuberculocidal claim) hospital disinfectant, wiped of chemical residue with a water-damp paper towel, and dried. Utilize the surface disinfecting protocol of the disinfectant manufacturer.
• Autoclaving does not remove debris that has accumulated on the sheath or the insert. Failure to adequately remove debris will result in inadequate sterilization. Rinse the Sheath and the insert under warm running water for 30 seconds to remove any external or internal soil or debris. Using a soft soapy cleaning brush to assist in the cleaning, if necessary. Use non-ammoniated detergent or dishwashing soap. Do not use ammoniated cleansers or disinfectants. Rinse the devices again under warm running water for 30 seconds to remove any residual soap and blot dry with a dry lint-free towel. Wipe Insert with a lint-free towel that has been saturated in an EPA-approved, hospital-grade intermediate or high-level disinfectant (minimum 2.5% Glutaraldehyde solution), following the instructions for use provided by the disinfectant manufacturer. Dry the devices with a dry lint-free towel.
• Sheaths and inserts must be sterilized in conventional steam autoclave capable of the following sterilization cycles followed by a 15-minute minimum cool-down period: Steam Sterilization Cycles: VACUUM: 132 +/- 2°C for 4 mins. GRAVITY: 132 +/- 2°C for 15 mins. A typical steam sterilization cycle is 132 +/- 2°C for 4 mins. (Vacuum) or 132 +/-2°C for 15 mins. (Gravity), followed by a 15 minute minimum cool-down period. Use a steam sterilization pouch that is compliant with ISO 11140-1 Type 4 and ISO 11607-1 standards. Once items are sterilized, adhere to the shelf-life specified by the pouch manufacturer. After sterilization, inspect the device in the autoclave bag for integrity. If suspicion about the item exists, discard it and order a replacement from Parkell or your dealer.
• THE SHEATH OR THE INSERT ARE NOT VALIDATED FOR USE WITH DRY HEAT OR CHEMICLAVE STERILIZATION. USE OF THESE METHODS MAY IRREVERSIBLY DAMAGE THE HANDPIECE OR INSERT AND VOID THE WARRANTY.
• Detachable handpiece sheath and ultrasonic inserts from Parkell are designed to withstand a minimum of 250 autoclaving cycles when reprocessed as per the recommended autoclaving instructions by the manufacturer.

How to Replace the Filter Disk

The water filter disk coming off of the rear hose of the unit should be replaced when it becomes dark or clogged with debris so that water flow is not blocked (1-3 months). Replacement Filters are available from Parkell (REF D419 – 10 per package).

1. Close any water valves, and bleed all water lines of residual water pressure.
2. Disconnect the scaler water supply hose from the water supply at the quick-connect.
3. Remove the old filter disk by holding it in one hand and loosening it by twisting it off the hose connectors on either side. They rotate in opposite directions.
4. Install the new filter disk in the same position as the old one, and tighten the connectors in reverse.
5. Reconnect the scaler water supply hose to the water supply via the quick-connect and check for leaks.
6. Note: If the filter becomes clogged and you do not have a replacement disk, the hose connectors may be locked together TEMPORARILY without the filter disk to allow emergency operation only.

Troubleshooting

Unit does not operate ("power on” indicator does not light):

• Transformer cable disconnected from wall outlet or scaler. Reconnect properly.
• Wall outlet not live. Reconnect properly.
• Foot Pedal or cable is damaged. Contact Parkell.
• Unit fuse has failed. Contact Parkell.

Insert does not vibrate properly:

• Faulty, damaged or worn insert. Replace.
• Insert not correctly seated in handpiece. Reinsert properly.
• Use a new Parkell® brand insert.
• Power control not correctly adjusted. Readjust.

Excess heat at handle or tip of insert:

• Faulty, damaged or worn insert. Replace.
• Too little water flow. Insert may be blocked. Inspect and clear blockage, or replace insert.
• Power too high for the amount of water. Increase water flow.
• Excessive hand pressure applied. Correct technique.

No water spray when foot pedal is depressed:

• Water line blocked or kinked. Correct.
• Water passage in the scaling insert clogged. Inspect and clear blockage, or replace insert.
• Water filter clogged. Replace.
• No water supply connected. Correct.

Insert does not go into handpiece:

• Insert stack is bent. Straighten plates carefully by hand and reinsert.
• O-ring is too tight. Lubricate O-ring with water and use twisting motion to seat insert.
• Autoclavable handpiece sheath is not attached to handpiece.

Insert falls out of handpiece or water leaks from front of handpiece:

• O-ring damaged or worn. Replace O-ring on insert and/or handpiece.

Water leaks at base of handpiece:

• Orange O-ring at end of handpiece is missing or damaged.

Insert comes out of handpiece when pedal is depressed:

• Water pressure is too high. Adjust water pressure to 15-35 psi at dental unit connection or in floor junction box, or replace insert O-ring.

User Maintenance and Authorized Service

The Parkell TurboSensor requires very little maintenance for years of trouble-free operation. There are no user-serviceable parts inside the control unit or the foot pedal. Opening the cases will void all warranties. Authorized Parkell personnel must make all internal repairs.

Parkell urges all scaler users to monitor the condition of the water filter periodically and change the filter whenever noticeable darkening of the disk occurs, or when water flow decreases. The most common reason for service for ultrasonic scalers is failure by the user to periodically change the water filter. This will result in contamination and clogging of the internal water components.

The ultrasonic inserts, handpiece sheaths, power supply, water filter and water hose are all detachable and may be replaced by the user. Contact Parkell for a list of authorized inserts and available replacement parts.

Within the US, all repairs must be made by Parkell. We maintain a complete service and parts facility in our factory at 300 Executive Drive, Edgewood, NY 11717. Equipment needing service in the US should be returned, freight pre-paid, via approved common carrier (e.g. USPS, UPS, FedEx), and adequately insured. Return all accessories with the unit, and include an explanation of the problem. Pack in the original box, add plenty of cushioning material, and overbox the unit during shipping. Transit should maintain a dry temperature of 0°F-110°F. You will be contacted for your approval of the repair, along with any associated costs, prior to any work. The unit will be repaired and returned to you.

Outside the US, repairs must be made by a Parkell-authorized facility.

If you have any questions or problems with the installation or use of your TurboSensor, call Technical Support Service at 1-800-243-7446, M-F from 8:30 AM to 5:00 PM EST.

Warranty and Terms of Use

For full Warranty and Terms of Use information, please see www.parkell.com. Parkell's Quality System is certified to ISO 13485.

Explanation of Symbols Used

This precision dental device was designed, manufactured and is serviced in the United States of America by:

parkell

300 Executive Drive, Edgewood, NY 11717

Toll-Free: (800) 243-7446 Phone: (631) 249-1134 • www.parkell.com

CEC REP Directa AB, Finvids väg 8, SE-194 47 Upplands Väsby, Sweden

MADE IN USA

UK UKRP: Topdental (Products) Ltd, 12 Ryefield Way, Silsden, West Yorkshire BD20, 0EF England UK