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Conformance to Standards:
The ELiTEDENT® Ultrasonic Scaler conforms to IEC60601-1-2:2001 and IEC60601-1-1:2000.
The device is CE marked corresponding to European Medical Device Directive (93/42/EEC)
Safety Precautions
Prior to installation and start-up of the Ultrasonic Scaler, carefully read the instructions provided herein!
Introduction
The Rolence ELiTEDENT® Ultrasonic Scaler is designed for use in prophylaxis treatments periodontia, and other areas of operative dentistry.
Rolence Enterprise Inc. is an ISO 9001, ISO 13485 certified manufacturer of Ultrasonic Scaler. The product is FDA registered and compliant with EN standards.
Contraindications and Warnings
Contraindications
1. Ultrasonic systems should not be used for restorative dental procedures involving the condensation of amalgam or porcelain.
2. This device is designed to work with all Cavitron® (remark) insert with 25 kHz or 30 kHz frequency automatically. For optimum performance please use only qualified inserts supplied by Cavitron® or Rolence Enterprise Inc.
3. Do not use this device if the patient or operator is wearing a pacemaker.
Remark: Cavitron® is a registered trademark of Dentsply® International, Inc.
Warnings
1. Persons who are 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. We recommend that the MS Handpiece Cable kept at least 6 to 9 inches (15 to 23 cm) away from any device and their leads during use.
2. During using the Ultrasonic Scaler, make sure that water is flowing continuously. If the MS Sterilizable Sleeve of handpiece overheats please check the water supply, and stop using the Ultrasonic Scaler for a while.
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Main Product:
Portable X-Ray ,
Curing Light,
Ultrasonic Scaler,
Curing Box,
Dental Digital Sensor,
UV Spot Curing
