Dental Ultrasonic Scaler Magneto Double Bottle

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.

Safety Precautions

Prior to installation and start-up of the Ultrasonic Scaler, carefully read the instructions provided herein!

Precautions for All Systems

1. Do not place the Ultrasonic Scaler on or next to a radiator or other heat source. Excessive heat may damage the Ultrasonic Scaler’s electronics. Place the Ultrasonic Scaler where air is free to circulate on all sides and beneath it.

2. Never operate the Ultrasonic Scaler without water flowing through the handpiece.

3. Always flush your ELiTEDENT® Ultrasonic Scaler system with clean water at least 30 seconds at highest flow after treatment.

4. Do not continuously operate the Ultrasonic Scaler for more than 20 minutes; try 5 minutes down time before reserving.

5. Equipment maintenance is strongly recommended.

6. Close the power switch every night before leaving the office.

7. Used for the intended purpose only. The Ultrasonic Scaler must be used by other than qualified and trained personnel, in medical facilities.

8. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade.

Precautions for Ultrasonic Prophylaxis Procedures

1. Before first use, clean, disinfect and sterilize new or repaired ultrasonic inserts you wish to use with the Ultrasonic Scaler.

2. Like a toothbrush, ultrasonic inserts "wear out" with use. Inserts with just 2 mm of wear lose about 50% of their scaling efficiency. In general, it is recommended that ultrasonic inserts be discarded and replaced after one year of use to maintain optimal efficiency and avoid breakage.

3. Always examine the Ultrasonic Scaler and ultrasonic insert tips before commencing treatment. If excessive wear is noted, or ultrasonic insert tips have been bent, damaged, or reshaped are susceptible to in-use breakage and should be discarded and replaced immediately.

4. Retract the lips, cheeks and tongue to prevent contact with the ultrasonic insert whenever it is placed in the patient's mouth.

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.

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)

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