Gnatus Jet Sonic User manual

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Technical Name: Equipment for Dental Prophylaxis by Sodium
Bicarbonate/Scaler.

Brand: GNATUS

Models: Jet Sonic Fit

Brand Name: Equipment for Gnatus Bicarbonate Jet/Scaler

Prophylaxis.

Manufacturer/ Distribuitor:

GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA.
Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Fone [phone] - Fax [phone]
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [e-mail]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
Registration ANVISA: 10229030040

INSTRUCTIONS FOR USE

ATTENTION

For greater safety:

Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.

PRESENTATION OF MANUAL

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3

INDEX

PRESENTATION OF MANUAL .........................................................................02

IDENTIFICATION OF EQUIPMENT .................................................................04

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06

TECHNICAL SPECIFICATIONS .......................................................................09

- Technical characteristics .................................................................................09

- Standards applied .........................................................................................10

- Dimension ....................................................................................................13

- Symbologies of packaging ..............................................................................15

- Symbologies of product. .................................................................................15

- Contents of the accessible and inaccessible markings .........................................16

INSTALLATION OF EQUIPMENT ....................................................................16

OPERATION OF EQUIPMENT .........................................................................18

- Turning on / Turning of the appliance ...............................................................18

- “Scaler” applications and techniques ................................................................19

PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................23

- Conditions of transport and storage .................................................................23

- Environmental conditions of operation ..............................................................23

- Sensitiveness to environmental conditions foreseeable in normal situations of use .23

- Recommendations for preserving the equipment. ...............................................24

- Precautions and warnings “during the installation” of equipment ..........................24

- Precautions and warnings “during the use” of equipment ....................................24

- Precautions and warnings “after” the use of equipment. .....................................25

- Precautions and warnings during the “cleaning and disinfection” of equipment .......25

- Precautions in case of alteration in the functioning of equipment ..........................26

- Precautions to be adopted against foreseeable or uncommon risks,

related to the deactivation and abandoning of equipment ......................................26

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............ 27

- Additional procedures for reuse....................................................................... 27

- Cleaning, disinfection and sterilization ..............................................................28

- Preventive maintenance ................................................................................ 28

- Corrective maintenance................................................................................. 29

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................30

WARRANTY OF EQUIPMENT ..........................................................................30

FINAL CONSIDERATIONS ..............................................................................31

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Dear Customer

Congratulations. You have made a good choice when you decided to buy a GNATUS
QUALITY product comparable to the best products available in the World. This manual is a
general presentation of your product and it will give you important details to help you to
solve possible problems.

Please, read it and keep this with you.

Identication

Technical Name: Equipment for Dental Prophylaxis by Sodium Bicarbonate/Scaler.
Brand: GNATUS
Models: Jet Sonic Fit

DESCRIPTION OF THE EQUIPMENT

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5

IDENTIFICATION OF THE EQUIPMENT

Description of Equipment

Equipment for prophylaxis with scaler and Bicarbonate Jet, modern and bold design,
assembled in a set composed of body and lid made out of ABS (Acrylonitrile, butadiene,
styrene) and digital control panel made out of polycarbonate. Available in the cart and
bench models.

Electric-pneumatic synchronized system, with valves that provide cuts and aspirations
of the water instantly, avoiding like this the contact of the water with the bicarbonate in
the point of the hand piece.

It has a Piezoelectric scaler activated through ceramic tablets at a frequency of 30,000
Hz. The Piezoelectric system of the transducer allows the use in operations without the use
of water.

Removable bicarbonate jet pen, with concentric diffuser which mixes the air, water and
bicarbonate at a small distance from the handpiece.

Cover of the transducer made out of rigid and autoclavable thermoplastic resin.

Potentiometer with a ne adjustment for precise adjustment of the ultrasonic power,

suited to each type of procedure.

Internal depressurization through automatic sweep of the bicarbonate, of the valves up
to the handpiece.

Container for bicarbonate easy to access, transparent and removable, which allows its
removal without needing to turn all the equipment upside down in order to remove the
remains of bicarbonate powder.

Bicarbonate jet interruption system with a module of anti-agglutination which avoids
the obstruction of the valves.

WORKING APPLICATION

• Distartarization

• Endodonty

• Periodonty

• Micro-recto surgery

Physical principle used by the Jet Sonic and Ultrasonic
equipment

The scaler is derived from physical vibrations of particles of material, similar to sound
waves, with a frequency exceeding the level of human perception, which produce a frequency
up to 30,000 vibrations per second.

The Bicarbonate Jet (Prophylaxis) comes from the release under pressure of particles of
sodium bicarbonate, together with the water, mixing together in the nozzle of the handpiece
forming jet in the form of a concentrated spray.

Indication of Equipment

This equipment is for dental use use only. It must be operated and utilized by specialized

professional (certied professional, according to the legislation of the country) and following

the instructions of the manual.

The operation of the equipment required, for the professional, the utilization of
correct instruments and it should to be in perfect conditions of the use, and to protect the
professional, the patients and others, in the eventual danger situation.

Purpose of the equipment

The Jet Sonic is an item of equipment for prophylaxis with scaler and bicarbonate jet,

which was developed to be used in several dental practices such as: periodontics,
endodontics, prosthesis, surgery, etc.

• Amalgam condensation

• Inlays - onlays condensation

• Gutta Percha Condensation

• Pines and crown removal

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION

01

02

03

05

06

07

08

01 - Switch with 3 positions:

• Turns on the Bicarbonate Jet;

• Turns off the equipment;

• Turns on the Scaler.

02 - Regulator of sonic variation

03 - Water ux regulator

04 - Jet of bicarbonate hand pieces
05 - Ultrasound hand piece
06 - Support of the points
07 - Actuation pedal
08 - Electrical cable
09 - Recipient of bicarbonate

10 - Air ux regulator

04

09

JET SONIC FIT

This equipment is also

available

in the Cart version.

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7

MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION

WATER TEE FOR RESERVOIR’S HOSE

CONNECTION

(DO NOT ACCOMPANY THE PRODUCT)

AIR TEE TO CONNECTION

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº 10P

FIXATION OF INSERTS KEY

PLUNGER

SILICON HOSE

TRANSDUCTOR COVER

BICARBONATE PACKAGES

(FREE REGISTRATION

BY HEALTH MINISTRY)

PEDESTAL

JET SONIC CART

(DO NOT ACCOMPANY THE

PRODUCT)

ELECTRICAL CABLE

WATER TEE FOR CONNECTION IN THE

FEEDING HOSE OF THE CONSULTIN

OFFICE

(DO NOT ACCOMPANY THE PRODUCT)

SINTERED FILTER OF 30 MICROS

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº 5-AE

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº 6-A

(DO NOT ACCOMPANY THE PRODUCT))

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INSERT Nº1

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº 2

(DO NOT ACCOMPANY THE PRODUCT)

INSERT NºH3

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº ET-20

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº ET-40

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº S-04

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº S12-90

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº P-14

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº A-120

(DO NOT ACCOMPANY THE PRODUCT)

INSERT Nº A-90

(DO NOT ACCOMPANY THE PRODUCT)

MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION

*ATTENTION: The

qu ipments hou ld
only be used with
the powe r i npu t
cable supplied by
Gnatus.

*ATTENTION: The

table shows all t he
optional items, your
Jet Sonic Fit will be
consisted of chosen
i tems d urin g the
purchase, according
to your choice.

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TECHNICAL SPECIFICATIONS

Model

Jet Sonic Fit

Classication of Equipment as per ANVISA:

Class II

Classication of Equipment as per standard IEC 60601-1:

Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1)

Protection against harmful water penetration

IPX 0

Mode of Operation

Continuous operation with intermittent load - 10min. work and 10min. rest.

Frequency of scaler

30.000Hz

Transducer system

Piezoelectric ceramic

General

Power Supply

Power Supply Voltage (Selectable)

127V~ ± 20% / 220V~ + 20%

- 10%

Frequency

50/60 Hz

Fuse

1A - (127/220V~)

Power

60VA

Consumed

0,43A

Net Weight Jet Sonic Fit 3,70kg Gross Weight Jet Sonic Fit : 4,50kg

Water inlet pressure

Maximum = 40PSI

Minimum = 20PSI

The materials used to produce the equipment are Biocompatible.

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TECHNICAL SPECIFICATIONS

Standards applied

This product was tested and approved in compliance with the following standards:

IEC 60601-1:2005 – Electromedical Equipment - Part 1: General prescriptions for safety;
EN ISO 980:2008 (Ed. 2) - Graphical symbols for use in the labelling of medical devices;
EN ISO 14971:2007 - Medical devices - application of risk management medical devices;
NBR ISO 9687: 2005 - Dental equipment - graphical symbols;
ISO 7494:2004 - Norma dental units;
EN ISO 13485-2003 - Quality systems - medical devices;
ISO 780:1997 - Packaging - pictorial marking for handling goods;
ISO 11144:1995 - Normal dental equipment - connections for supply and waste lines;

IEC 60601-1:2007 – Electromagnetic Compatibility.