Medidenta Sonus Instructions de fonctionnement

Medidenta

Toll Free: 800.221.0750

Web: www. Medidentaendo.com

Email: [email protected]

3575 W. Post Rd. , Las Vegas, NV 89118

LED Piezo U l trason ic Scaler

User and Operating Manual

Read this manual carefully before operating.

Keep it in a safe place for further consultation

Contents

1. Installation. Components description ........................................... 3

2. Installation. Setup .......................................................................... . 7

3. Maintenance. Troubleshooting.................................................... 16

4. Cleaning, disinfection and sterilization ...................................... 20

5. Precautions. Contraindications……………………………….... 27

6. After service ...................................................................................32

7. Symbolsinstructions.....................................................................33

8. Environmental protection .............................................................34

9. Manufacturer’s liability..................................................................34

10. European authorized representative ..........................................34

11. EMC - Declaration of conformity .................................................35

12. Statement........................................................................................39

13. Tips Power Table ........................................................................... 40

1. Installation. Components description.

1.1 Introduction

Thanks for purchasing the SonusTM LED Piezo Ultrasonic Scaler.

The Medidenta medical device that you are about to install

and use in your practice is a medical device designed for

professional use. It comprises the chosen tool with which you will

provide treatment within the context of your work.

To ensure optimum safety for yourself and your patients, comfort in

your daily practice and to benefit fully from the technology of your

medical device, please read the documentation provided carefully.

If youhave received this medical device by mistake, please contact

Medidenta to arrange for it to be collected.

This piezoelectric unit is used for preservation and restoration

dentistry, including hygiene, periodontics, endodontics,implant

maintenance, restorative and prosthesis.

WARNINGS:

•Read all instructions before operating this unit. The manufacturer

accepts no liability for any damage resulting from improper use of this

unit and/or for any purpose other than those covered by these

instructions.

•US Federal law restricts this unit to sale by or on the order of a

dentist.

•As per Endodontic Standards of Care, always use a rubber dam

when performing endodontic treatment.

•Do not use dry heat sterilization on any of the device’s components.

1.2 Components description

1.2.1 The components are listed in the packing list.

1.2.2 Sonus LED Piezo Ultrasonic Scaler is composed of circuit board,

water pump, reservoir (tank and accessory bottles), and ultrasonic

transducer handpiece.

1.2.3 Sonus LED Piezo Ultrasonic Scaler is used dental procedures

such as hygiene, periodontics, endodontics, implant maintenance

and cavity preparations.

1.3 Technical specifications

1.3.1 LED Piezo Ultrasonic Scaler:

a) Main unit input: 110V~ 50Hz/60Hz 280 mA.

b) Output primary tip vibration excursion: ≤90μm.

c) Output half-excursion force: <2N.

d) Output tip vibration frequency: 28kHz±3kHz.

e) Output power: 3W to 20W.

f) Main unit fuse: T0.5AL 250V.

g) Water pressure: 0.01MPa to 0.5MPa.

h) Weight of main unit: 3.97 pounds (1.8 Kg).

i) Operating mode: Continuous operation.

j) Type of protection against electric shock: class II equipment.

k) Degree of protection against electric shock: Type BF applied part.

l) Applied part of the equipment: handpiece and tip. Degree of

protection against harmful ingress of water: ordinary equipment.

Foot switch is drip-proof equipment (IPX1).

m) Degree of safety of application in the presence of a flammable

anesthetic mixture with air, oxygen or nitrous oxide: equipment not

suitable for being used in the presence of a flammable anesthetic

mixture with air, oxygen or nitrous oxide.

1.4.2 Main components

Main unit (front)

Fig. 1. Front view details.

Main unit (back)

Fig. 2. Back view details.

Handpiece components

Fig. 3. Handpiece.

Handpiece/handpiece cable coupling

Fig. 4. Handpiece and handpiece cable connection alignment guides

matching.

Tip installation. Torque Wrench/ Wrench

Fig. 5. Torque wrench and wrench.

Touch screen display with water, vibration and power (amplitude)

controls.

Fig. 6. Touch screen display.

Accessory bottles.

Fig. 7. Accessory bottles (300 ml maximum) for irrigants.

2. Installation/Setup

2.1 Unpacking the device

WARNING:

When you receive your medical device, check for any damage that

may have occurred during transportation. If you have received this

medical device by mistake, please contact the supplier to arrange for

it to be collected.

2.1.1 Open the packing box. Make sure that all parts and

accessories are complete according to the packing list. Take the main

unit out of the box, and place it on a secure and flat surface facing to

the operator.

2.1.2 Installing cords. Check if the cords do not hinder the

movement or free circulation of anyone.

2.1.3 Never rotate the handpiece connector on its cord as this

can damage your medical device.

2.1.4 Never wrap the handpiece cord around the medical

device.

2.1.5 Make sure that it is not possible to wheel over or walk on

the different cords.

2.1.6 Set the device to OFF position (power switch, Fig. 2).

Check that the power voltage is compatible with that indicated

on the device or its power plug.

WARNING:

Sonus voltage is 110V, 50-60Hz, 280 mA.

2.1.7 Next, connect the cord to the wall socket in compliance

with the standards in force in the country of use.

2.1.8 A different voltage would cause damage to the medical

device and could injure the patient and/or user. Any variation in

the electrical network voltage or electromagnetic field that is

non-compliant with the limits in force, could interfere with the

medical device’s operation.

2.1.9 The medical device’s ground must be connected to a

supply network equipped with a protective ground.

2.1.10 Turn the irrigation flow control knob (Fig. 1) to maximum

turning the knob counterclockwise. Turn the water line flow control

knob (Fig. 2) to maximum turning the knob counterclockwise. Do not

screw it over tight.

2.1.11 Insert the foot pedal cord plug to its socket (Fig. 2).

If you are going touse the water line:

2.1.12 Connect one end of the water pipe to the water entrance, and

the otherend to the clean water source (Fig. 2).

NOTE:

The water line hoseand its connectors are not included in this

device package.

WARNINGS:

•The CDC recommends that dental unit water used in

nonsurgical procedures measure less than or equal to 500 colony

forming units of heterotrophic bacteria per milliliter (≤500 CFU/mL)

of water, the standard set for drinking water by the Environmental

Protection Agency (EPA).

•Use sterile saline or sterile water as a coolant/irrigant when

performing surgical procedures (such prophylaxis, scaling and/or

periodontics treatments).

•Follow dental unit manufacturer’s instructions for maintaining

and monitoring the quality of dental unit water.

2.1.13 With the water connections in place, press the water line mode

button on the touch panel (Fig. 6).

If you are going to use the reservoir (tank) or bottles:

WARNING:

The device is equipped with a reservoir (tank) and accessory bottles

(Fig. 7) designed to hold the irrigation solution. The irrigation solution

reservoir is fitted with a cover. Neither the reservoir, the cover or

accessory bottles can be sterilized.

2.1.14 Fill the reservoir up to the line with distilled water. Do not

overfill. With the reservoir/bottles in place, press the

reservoir mode button on the touch panel (Fig. 6).

2.1.15 Sonus comes with accessories bottles (Fig. 7) to be used

during endodontic irrigation. Place the bottle for different solutions

activation/irrigation.

WARNING:

Do not leave the reservoir (original tank or accessorybottles) with

irrigants in place after finishing the procedure. The permanent

contact of the reservoir/bottles filled with endodontic irrigants (i.e.,

sodium hypochlorite, EDTA, chlorhexidine and others) can cause

permanent corrosion of the internal parts of the device.

2.1.16 Choose the tip accordingly (see tips Tip Power Table, pg. 40),

and install it using the torque wrench (Fig. 5). For install endodontic

(E) tips, use the wrench (both included).

WARNING:

The screw thread of the tips produced by other manufacturers

maybe coarse, rusty and collapsed, which will damage the

screw thread of the handpiece irretrievably. Please use Medidenta

brand tips.

2.1.17 Turn on the power switch (Fig. 2).

WARNING:

Every time that the device is turn off and turn on again, the system

will be pre-configurated for power (amplitude) 1, vibration mode E

(for endodontics tips) and reservoir/tank/bottle irrigant mode (Fig. 8).

Fig. 8. Pre-set configuration after turning the device on.

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