Dental Piezo Scaler Metal Housing

Introduction

Rolence Enterprise Inc. is an ISO 9001, ISO 13485 certified manufacturer of Ultrasonic Scalers. All the products are FDA registered and compliant with EN standard (CE Marking).

Conformance to Standards:

ELiTEDENT® PS-1/PS-1(LED) 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)

Application

The Ultrasonic Scaler is designed for use in dentistry for the following applications:

- General Scaling (G)

Removal of supragingival calculus

Removal of stains

- Endo (E)

Preparation, cleaning and irrigation of root canals

Retrograde preparation of root canals

- Perio (P)

Scaling and root planning

Periodontal treatments

Installation Instructions

General Information

If the installation of your ELiTEDENT® Ultrasonic Scaler is performed by someone other than trained Rolence distributor personnel, care should be taken to observe the following requirements and recommendations.

Water Line Requirements

1. The System's water supply line is factory installed. Do not disconnect from the Ultrasonic Scaler.

2. Incoming water supply line pressure to the Ultrasonic Scaler must be 20 psi (138 kPa minimum) to 60 psi (414 kPa maximum). If your dental water system's supply line pressure is above 60 psi, install a water pressure regulator on the water supply line to your Ultrasonic Scaler.

3. A manual shut-off valve on the dental water system supply line should be used so that the water can be completely shut-off when the office is unoccupied.

4. A filter in the dental water system supply line is recommended so that any particles in the water supply will be trapped before reaching the Ultrasonic Scaler.

5. After the above installations are completed on the dental water supply system, the dental office water line should be thoroughly flushed prior to connection to the System.

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. Do not cover vents on rear panel.

2. Always set the system's power adjustment to the lowest power setting for the application of a new or special Tips.

3. Always flush your Ultrasonic Scaler system for at least 30 seconds with highest flow after treatment.

4. Do not operate the system in “Turbo” mode continuously for more than 20 minutes! Try to take a 10 minute break before re-use the system.

5. Equipment and dental water supply system maintenance are strongly recommended.

6. Close the water shut-off valve in the dental water supply system every night before leaving the office.

7. The use of an in-line water filter is recommended.

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

9. 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 handpieces and Tips you wish to use with the Ultrasonic Scaler.

2. Always examine the unit and ultrasonic tips before commencing treatment. A damaged Ultrasonic Scaler or damaged tip must not be used.

3. Ultrasonic tips that 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 tip whenever it is placed in the patient's mouth.

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