GNATUS Syncrus G3 H User manual

2
PRESENTATION OF MANUAL
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 [phone] - Fax [phone]
C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115
www.gnatus.com.br - [email protected]
Technical Duties: Gilberto Henrique Canesin Nomelini
CREA-SP: 0600891412
Registration ANVISA #: 10229030047
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.

33
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

4
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.
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.
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.
Indication of Equipment
Identication
Technical Name: Dental Delivery Units and Accessories
Trade Name: Syncrus G3 H Delivery Unit
Brand: GNATUS
Illustrative image.

55
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 multi-
functionality 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.
Description of Equipment
* Optional
IDENTIFICATION OF EQUIPMENT

6
- 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.
*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
*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.).
* Optional
IDENTIFICATION OF EQUIPMENT

77
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
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
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
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.
*
*
*
*
*
*
*
*
*
*
*
A
B
08
B
A
02
07
01
03
04
05
06
08
09
14
16
15 15 15
10 12 1311
* Optional

8
01
04 05
11
13
03
06
02
10 12
14
0907 08
15
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION

99
01.Terminals:
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)
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
Equipment with nomenclature "FULL" may
contain some optional in the set, such as:
FO / MME / OPTI / SONIC /PAD, etc. ...
Equipment conguration
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.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
* Optional

10
TECHNICAL SPECIFICATIONS
General
Technical features of the Delivery Unit and its accessories
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
Other specications
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~
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

1111
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.
TECHNICAL SPECIFICATIONS

12
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.
The is made to be used in the electromagnetic environments specified below. The
client or the user of the must be sure that it is used in such environment.
equipment
equipment
Eletromagnetic emissions
Emission test Compliance
Eletromagnetic environment - Guide
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
This equipment is proper to be used in
all establishments; including domestic
settings and those directlyconnecttoa
public low voltage distribution which
feeds domestic buildings.
The materials used to produce the equipment are Biocompatible.
Pay attention while using this equipment together with other movable equipment, in
order to avoid collisions.
Use of different cables, transducers and accessories from those specied may result
in increased emissions or decreased immunity of the equipment.
TECHNICAL SPECIFICATIONS
Electromagnetic Emissions

1313
Guidelines and manufacturer's declaration - electromagnetic immunity
The is made to be used in the electromagnetic environments specified below. The
client or the user of the must be sure that it is used in such environment.
equipment
equipment
Therecommended power
supplyqualityisthe same as
used forcommercial or
hospital environment. If is
required acontinuous use
during energy supplyoutages,
it is recommendedthatthe
equipmentbefeed by an
uninterruptible power supply
or abattery.
If an imagedistortion occurs,
maybenecessary placethe
equiomentfar from thesupply
frequencyortoinstalla
magneticarmour. The
frequency magneticfield shall
be measuredatthe
installmentplace to assure
that it is lowenough.
Immunity
test
ABNT Test level
NBR IEC 60601
Level of
compliance
Electromagnetic environment
Directives
Electrostatic
discharge(ESD)
IEC 6100-4-2
Quick electric
transitory phases /
train of pulses
(”Burst”)
IEC 61000-4-4
Surges
IEC 61000-4-5
Reduction,
interruption
and variance of
voltage in
power supply
input lines
IEC 61000-4-11
Magnetic field in
frequency of
power supply
(50/60Hz)
IEC 61000-4-8
3 A/m 0,3 A/m
± 6 kV Contact
± 8 kV Air
± 6 kV
± 8 kV
Contact
Air
± 2 kV in power
supply lines
± 1 kV lines (s) to
lines (s)
± 1 kV lines (s) to
lines (s)
± 2 kV in power
supply lines
± 1 kV in input /
output lines
± 2kV lines (s) to
ground
± 2kV lines (s) to
ground
± 1 kV in input /
output lines
<5%
(>95% drop in )
for 0,5 cycle
40%
(60% drop in t)
for 5cycles
70%
(30% drop in )
for 25 cycles
<5%
(>95% drop in )
for 5s
U
Ut
U
U
U
U
U
U
t
t
t
t
t
t
<5%
(>95% drop in )
for 0,5 cycles
40%
(60% drop in )
for 5cycles
70%
(30% drop in )
for 25 cycles
<5%
(>95% drop in )
for 5s
U
U
U
U
U
U
U
U
t
t
t
t
t
t
t
t
NOTE Ut is the a.c. power supply voltage before the application of the test level
Floorsshouldbewooden,
concreteorceramic. If the
floor is covered with
synthetic material, the
relative humidityshouldbe
at least 30%
It is advisable that the
qualityof the power supply
should be that of hospital or
typical commercial
environment
It is advisable that the
qualityof the power supply
should be that of hospital or
typicalcommercial
environment
Electromagnetic Emissions
TECHNICAL SPECIFICATIONS

14
Guidelines and manufacturer's declaration - electromagnetic immunity
Immunity
test
ABNT test level
NBR IEC 60601
Level of
compliance
Electromagnetic Environment
Directives
The field intensities set by the fixed transmitters, such as radio base stations, telephones (mobile
phone, wireless) land mobile radio, amateur radio, AM and FM radio transmissions and TV
transmissions can not be predicted with accuracy. Due to the RF fixed transmitters is recommended to
install an electromagnetic inspection at the local in order to evaluate the electromagnetic environment.
If at the place where the equipment is be using the field intensity level exceeds the conformity level for
the RF above, is recommended to observe if the operations are normal. Whether abnormal operations
are observed, additional procedures shall be necessary such as reorientation or replace the
equipment.
Whether above the frequency range of 150kHz to 80 MHz is recommended a field intensity below than 3
V/m.
The is made to be used in the electromagnetic environments specified below. The
client or the user of the must be sure that it is used in such environment.
equipment
equipment
RF conducted
IEC 61000-4-6
RF radiated
IEC 61000-4-3
3 vrms
150 kHz up to 80 MHz
3 V/m
88 MHz up to 2,5 GHz
3 Vrms
3 V/m
It is advisable that portable and
mobile RF communication equipment
is not used near any part of the
equipment, including cables, with a
separation distance less than the one
recommended, calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation distance:
d=1,2 P√
d=1,2 P80 MHz thru 800MHz
d=2,3 P 800 MHz thru 2,5MHz
Where Pis the nominal maximum
power of output of the transmitter in
watts (W), as per the manufacturer of
thetransmitter, anddisthe
recommended separation distance in
meters (m).
It is advisable that the fiel intensity
from theRF, transmitteras
determined by means of electric
inspection on-site, ªis less than the
level of compliance in each frequancy
range .
There maybe interference near the
equipment marked with the following
symbol:
√
√
b
a
b
NOTE 1 At 80MHz and 800MHz, the highest frequency range applies.
NOTE 2 These directives may not be applicable in every situation. The electromagnetic
transmission is affected by the absorption and reflection of structures, objects and people.
Electromagnetic Emissions
TECHNICAL SPECIFICATIONS

1515
Recommended distances between portable and mobile RF
communication equipments and the equipment
The is made to be used in an electromagnetic environment in which RF
disturbances are controlled. The client or the user of the may help preventing
electromagnetic interference by keeping a minimal distance between mobile and portable RF
communication equipment (transmitters) and the ,as recommended below,in
accordance with the maximal voltage output of the communication equipment.
equipment
equipment
equipment
Transmitter Maximum
Output (W)
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
150 kHz to 80 MHz
d= 1,2 p
√
80 kHz to 800 MHz
d= 1,2 p
√
800 kHz to 2,5 GHz
d= 2,3 p
√
For transmitters withamaximum nominal output power not listed above, the recommended d separation
distance in meters (M) can be determined using an equation applicable to the frequency of the transmitter,
where Pis the transmitter maximum nominal output in watts (W) according to the transmitter
manufacturer.
At 80 MHz and 800 MHz, is applied the separation distance for the higher frequency range.
These guidelines may not apply to all situations. The absorption and reflection from structures,
objects and people affect the electromagnetic propagation.
NOTE 1
NOTE 2
Separation distance according to transmitter frequency (M)
Electromagnetic Emissions
TECHNICAL SPECIFICATIONS

16
Dimensions (mm)
TECHNICAL SPECIFICATIONS

1717
TECHNICAL SPECIFICATIONS
Packing symbols
Careful : It indi cates an important
instruction for the operation of the
product. Not following it can cause
dangerous malfunctioning.
Note: It indi cates useful
information for operation of the
product.
Important: It indicates an
instruction of safety for operation
of the product. Not following it,
can lead to serious danger to the
patient.
Landing (in many parts of the
equipment) indicates the condition
of being landed.
Turned on position
Turned off position
B type equipment
Product symbols
Lift seat.
Lower seat.
Lift backrest.
Lower backrest.
It determines to spitting position
/ last position.
It determines the maximum
quantity of boxes which can be
stacked during transportation
and storage “as per packaging”.
Packing to be transported and /
or stored with the harrows up.
Packing to be transported and /
or stored with care (should not
suffer drop and neither receive
impact).
Packing to be transported and
/ or stored avoiding humidity,
rains and wet oor.
The packing must be stored and
transported away from direct
sun light exposure.
Temperature limit for the
packing to be stored or
transported.

18
TECHNICAL SPECIFICATIONS
Product symbols
It determines the work position
“1”.
If determines the work position
”3”.
If determines the work
position ”2”.
If determines the work
position ”4”.
Bio-System operation
High-speed with FO
Curring Light
Triple syringe
Emergency stop
Bowl’s water ow
Cup lling
X ray view operation
Electric low-speed-motor
Ultrasound
Electric low-speed-motor
rotation inverter
Warning - Consult the manual
Bicarbonate Jet
Dental Light
It determines the initial position. Authorized representative in
the European Community

1919
Content of accessible and non-accessible demarcations
INSTALLATION OF EQUIPMENT
- This equipment shall only be able to be unpacked and installed by a Gnatus authorized
technician, under penalty of losing the warranty, as only (s)he has the information, suitable
tools and training required to execute this task.
- Gnatus bears no responsibility for damages or accidents caused by poor installation
executed by a technician not authorized by Gnatus.
- Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.
These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized
Gnatus technician.
The installation of this equipment requires specialized technical
assistance (Gnatus).
Standards applied:
NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para segurança;
NBR ISO 14971:2004- Medical devices - application of risk management medical devices;
NBR ISO 9687: 2005 - Dental equipment - graphical symbols;
EN ISO 13485-2003 - Quality systems - medical devices;
IEC 60601-1-2:2007 - Compatibilidade Eletromagnética.
OPERATION OF EQUIPMENT
Turning on / o the dental set
Turn on the main switch of the Dental Chair. All the functions of the equipment will be
enabled.
The main switch has an internal LED which goes on when the dental chair is turned on.
TECHNICAL SPECIFICATIONS