Gnatus Syncrus G3 H User manual

PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
Technical Name: Dental Delivery Units Trade Name: Syncrus G3 H Delivery Unit Brand: GNATUS
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 +55 (16) 2102-5000 - Fax +55 (16) 2102-5001 C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115 www.gnatus.com.br - gnatus@gnatus.com.br
Technical Duties: Gilberto Henrique Canesin Nomelini CREA-SP: 0600891412
Registration ANVISA #: 10229030047
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.
2
INDEX
PRESENTATION OF MANUAL ........................................................................02
IDENTIFICATION OF EQUIPMENT .................................................................04
- Indication of Equipment ................................................................................04
- Principles and bases applied to the functioning of the product..............................04
- Description of Equipment ...............................................................................05
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....07
TECHNICAL SPECIFICATIONS .......................................................................10
- Technical features of the Delivery Unit and its accessories ...................................10
- Electromagnetic emissions ..............................................................................12
- Dimensions ..................................................................................................16
- Packing symbols ...........................................................................................17
- Product symbols ...........................................................................................17
- Standards applied .........................................................................................19
- Content of acessible and non-accessible demarcations .......................................19
INSTALLATION OF EQUIPMENT ....................................................................19
OPERATION OF EQUIPMENT .........................................................................19
PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................28
- Transportation, storage and operation ..............................................................28
- Sensitivity to environmental conditions in normal situations of use .......................28
- Precautions and warnings “during the installation” of equipment ..........................28
- Recommendations for the dental equipment maintenance. ..................................29
- Precautions and warnings “during the use” of equipment ....................................29
- Precautions and warnings “after” the use of equipment ......................................29
- Precautions and warnings during the “cleaning and disinfection” of equipment .......30
- Precautions in case of alteration in the functioning of equipment ..........................30
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment ......................................30
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............31
- Additional procedures for reuse .......................................................................31
- Cleaning ......................................................................................................31
- Disinfection ..................................................................................................31
- Preventive Maintenance .................................................................................33
- Corrective Maintenance ..................................................................................33
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................34
WARRANTY OF EQUIPMENT ..........................................................................35
FINAL CONSIDERATIONS ..............................................................................35
33
IDENTIFICATION OF EQUIPMENT
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.
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.
Principles and bases applied to the functioning of the product
It has hoses with compressed air and connectors for the supply of handpieces (high and low rotation) and a syringe with air and water outlet.
Identication
Technical Name: Dental Delivery Units and Accessories
Trade Name: Syncrus G3 H Delivery Unit
Brand: GNATUS
Illustrative image.
4
IDENTIFICATION OF EQUIPMENT
Description of Equipment
Dental use equipment, for actuation and control of the syringe, rotary instruments and
others, providing the best proximity to the operative eld; ambidextrous (serves right and
left-handed users).
Set made of steel structure with ABS body injected with anti-UV protection. Flat paint high gloss epoxy-based, cured in an oven at 250 ° C, with phosphate treatment corrosion resistant and cleaning materials.
FLEX type pneumatic Model with stroke limiter stop. Attached to the chair, with wide horizontal and vertical movement, with pneumatic locking, powered by button located under the handle of the equipment, providing smoothness in movements and stop at the desired position.
Movement of tips through retractable rods with lock for relief in the tension of the hose (except from triple syringe Stem), which provides lightness of movements, allowing greater
proximity to the operative eld
Automatic selection of tips through individual pneumatic valves, allowing lightness in your drive.
Flexible support for hand pieces is removable and autoclavable, protecting them against impact
Smooth Hoses, rounded, light and exible, without grooves or ridges.
Support for tray attached to the catheter with horizontal movements.
Bilateral handles.
* Equipped with side control panel contains a set of all commands for the chair, equipment
functions, water unit and light reector.
* Bio-System: Disinfection system provided with check valve, which provides the internal cleaning hoses and terminals with bactericidal liquid, preventing risk of cross contamination.
To ensure safe operation of your equipment, use only assembly congurations (Chair, Equipment, Water Unit and Light reector) provided by Reseller / Gnatus Authorized Service.
ISO 9001 and ISO 13485 Quality system, ensuring that products are manufactured within standard procedures.
Products are manufactured according to the RDC 16/13 - National Health Surveillance Agency – ANVISA resolution.
* Curing Light
Product Features:
Designed to carry out curing resin material through a curing process. The wavelength of 440nm - 460nm associated with high energy emitted by Curing Light enables the multi­functionality of this device.
It has high power LED with efcient coupling and optical distribution, providing speed
and security procedures. Ensures proper photo-activation of materials without wasting light.
The LED system of this machine has long service life, equivalent to 36 million 10-second
cycles without loss of power and efciency in the photo activation.
The reduced weight of the pen and its anatomical design ensure a more comfortable and practical professional work.
Operation control with display and buttons on the pen itself.
Programmable operating time.
- 10, 20, 40, 60, 80 and 90 seconds with sound signal (beep) every 10 seconds.
- Shows the elapsed time and the end of the operation.
- No special optical lters.
- Low power consumption.
* Optional
55
IDENTIFICATION OF EQUIPMENT
- Low cost of replacement.
The cold light does not emit heat as conventional bulbs - Low temperature light polymerizes the resin without damaging the tooth pulp and prevents thermal expansion problems.
- The forced ventilation system, transmitting unpleasant noise is not necessary.
- High strength piece
Conductive light removable tip, made of high strength polymer and easy maintenance
- Suitable for single bleaching or up to three teeth.
Swivel eye protection - Ensures full protection without compromising the visual eld.
*Ultrasound
Product Features:
Piezoelectric Ultrasound, frequency of 30,000 Hz.
The transducer with piezoelectric system allows the insert to perform accurate movements and linear and can be used in various dental specialties.
Fine power adjustment, suitable for each type of procedure.
For proceedings with refrigeration provides constant irrigation with ow control. It also
allows the execution of dry work (amalgam condensation, cementing inlays / on lays, etc.).
*Digital Control Panel Kit "electric micro motor Bien Air"
Product Features:
See Owner's Manual - Digital control panel
*Bicarbonate jet SET/ Hand Jet
Product Features:
See Owner's Manual – Hand jet
* Optional
6
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
The contents of this page are of an informative nature, the equipment being able to differ from that illustrated. So, upon acquiring the product check the technical compatibilty between equipment, coupling and accessories.
07
A
14
16
15 15 15
01
02
03
09
08
08
06
05
B
A
04
B
10 12 1311
01 - Bilateral Catcher 02 - Triple syringe
*
03 - High-speed-motor terminals
*
04 - Micro motor terminal
*
05 - Control panel (PAD)
*
06 - X ray view
*
07 - Auxiliary tray 08 - Articulated arm
* Optional
09 - Column arm 10 - Power (power ultrasound adjustment)
*
11 - Speed (electric microengine power adjustment)
*
12 - Light (electric microengine brightness adjustment)
*
13 - Manometer
*
14 - Arm brake valve 15 - Water records for FO/MME/Ultrasound
*
16 - Bio-System operation
*
77
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
01
04 05
10 12
02
11
03
06
0907 08
13
14
15
8
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
01. Terminals:
*
16
The drawings (page 08 and 09) illustrates all
optional items; therefore,
your equipment will consist only of items selected during your purchase option.
The use of any part, accessory or material
not specied or foreseen
in these instructions for use is entirely the user’s responsibility.
Borden terminal (TB) Midwest Terminal (TM) Fiber Optic Terminal (FO) Electric micro motor Terminal (MME)
02. Curing Light + tip for 3 teeth
*
(OPTI)
03. Triple syringe with fully metal
*
body or injected thermoplastic handle "optional heater set"
04. Auxiliary Tray /
*
instrument support
05. Bicarbonate Jet set, Hand (JET)
*
06. Progressive pedal with drive / water
*
cut
07. Ultrasound set (SONIC)
*
08. Digital control panel set MME Bien
*
Air (FULL)
09. Stainless steel cover
*
10. Control panel with built-in
*
negatoscope (PAD)
11. Progressive Pedal
*
12. Triple syringe with fully injected
*
thermoplastic body "optional heater set"
13. Integrated Pedal "Chip Blower"
*
14. Manometer
*
15.Negatoscope set
*
16.MME Bien Air set (MME)
*
* Optional
Equipment conguration
Equipment with nomenclature "FULL" may contain some optional in the set, such as:
FO / MME / OPTI / SONIC /PAD, etc. ...
99
TECHNICAL SPECIFICATIONS
Technical features of the Delivery Unit and its accessories General
Model Syncrus G3 H Delivery Unit
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)
Power Supply
Power Supply Voltage (coming from dental chair) 127/220 V~ (Selectable) Frequency 50/60 Hz Input fuse (coming from dental chair) 5A Delayed action Voltage in equipment (coming from dental chair)
12 and 24 V~
Other specications
Inlet air pressure 60 a 80 PSI ±2 Capacity of reservoir - Water / Bio-System* (coming from water unit) 1000 ml* / 800 ml* Maximum capacity of load applied to trays 1Kgf Net weight 26 Kg Gross weight 31 Kg Dimensional support tray (mm) 385 x 300
* Optional
10
TECHNICAL SPECIFICATIONS
Specications of Curring Light
Power 5,2VA Light source 1 LED Active medium Semicondutor Led (InGaN) Wavelength 440nm - 460nm Timer 90 seconds Timer alarm Sound alarm with beep every 10 seconds and 4 beeps at the end of the cycle Activation Through the hand-piece button Light conductor Made out of special polymer, rotational, removable and reuse sable. Hand-piece body ABS injected
Specications of Ultrasound
Transducer protective cover, removable and autoclavable. Autoclavable tool to replace the inserts. Frequency of Vibrations of Ultrasound
30.000Hz Consumption of irrigating liquid 28 ml/min Power consumed 15VA ±10% Transducer system Piezoelectric ceramic Electronic circuit with frequency stabilizer. Keeps the vibration even when there is network voltage oscillation.
1111
TECHNICAL SPECIFICATIONS
Pay attention while using this equipment together with other movable equipment, in order to avoid collisions.
The materials used to produce the equipment are Biocompatible.
Use of different cables, transducers and accessories from those specied may result
in increased emissions or decreased immunity of the equipment.
Electromagnetic Emissions
Eletromagnetic emissions
The is made to be used in the electromagnetic environments specified below. The
equipment
client or theuser of the must be sure that it is used in such environment.
equipment
Emission test Compliance
RF emissions ABNT NBR IEC CISPR 11
RF emissions ABNT NBR IEC CISPR 11
Emissions of harmonics IEC 61000-3-2
Fluctuation of Voltage / Emissions of flicker
IEC 61000-3-3
Group 1
Class B
Class A
As per
Eletromagnetic environment - Guide
This equipment uses RF energy only for internal functions. However,its emissions are too low and it's unlikely to cause any interferenceinthe equipments next to it.
This equipment is proper to be used in all establishments; including domestic settings and those directlyconnecttoa public low voltage distribution which feeds domestic buildings.
12
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