GNATUS Syncrus G3 User manual

2
Technical Name: Odontological cuspidor
Brand: Gnatus
Trade Name: Syncrus G3 Water Unit
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 nº: 10229030062
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

33
INDEX
PRESENTATION OF MANUAL .......................................................................... 02
IDENTIFICATION OF EQUIPMENT ................................................................... 04
- Indication of Equipment .................................................................................. 04
- Principles and fundamentals applied to the product functioning.............................. 04
- Description of Equipment ................................................................................. 05
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION ....... 07
TECHNICAL SPECIFICATIONS ......................................................................... 11
- Technical features of the Delivery Unit and its accessories..................................... 11
- Standards applied ........................................................................................... 12
- Electromagnetic emissions................................................................................ 13
- Dimensions .................................................................................................... 16
- Packing symbols ............................................................................................. 18
- Product symbols ............................................................................................. 18
- Content of accessible and non-accessible demarcations ....................................... 19
INSTALLATION OF EQUIPMENT ...................................................................... 19
EQUIPMENT OPERATION ................................................................................ 20
PRECAUTIONS, RESTRICTIONS AND WARNINGS ............................................ 25
- Transportation, storage and operation ................................................................ 25
- Sensitivity to environmental conditions in normal situations of use......................... 25
- Precautions and warnings “during the installation” of equipment............................ 25
- Recommendations for the dental equipment maintenance..................................... 26
- Precautions and warnings “during the use” of equipment ...................................... 26
- Precautions and warnings “after” the use of equipment ........................................ 26
- Precautions and warnings during the “cleaning and disinfection” of equipment......... 27
- Precautions in case of alteration in the functioning of equipment............................ 27
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment........................................ 27
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION.............. 28
- Additional procedures for reuse ......................................................................... 28
- Cleaning ........................................................................................................ 28
- Disinfection .................................................................................................... 28
- Preventive Maintenance ................................................................................... 31
- Corrective Maintenance.................................................................................... 31
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS .......................................... 32
WARRANTY OF EQUIPMENT ............................................................................ 34
FINAL CONSIDERATIONS................................................................................ 34

4
Illustrative image.
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.
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: Odontological cuspidor
Trade Name: Water Unit Syncrus G3
Brand: GNATUS
Principles and fundamentals applied to the product functioning
Auxiliary waste collector unit, has suctors which suction is caused by venturi system or
vacuum pump with compressed air.
IDENTIFICATION OF EQUIPMENT

55
Water unit for dental use, for auxiliary works as water supply source and waste collection
from spitter bowl and sucking devices; ambidextrous (serves right and left-handed users),
attached to the chair, * actuated by optical sensor.
The frame is manufactured with steel structure, ABS injected body with anti-UV
protection. Smooth high glossy paint, epoxy-based, cured in an oven at 250° C, with
phosphate treatment resistant to rust, corrosion and cleaning chemicals.
Upper body of the unit conveniently located for better spitting position. Can be turned
60º, prioritizing ergonomics and allowing approach of the assistant.
Ceramic bowl spittoon, deep and easily removable for hygiene and asepsis, supplied
with strainer drain for solids retention.
Smooth hoses, rounded, soft and exible, without grooves or striations and quick connect
coupling that easily without the need for tools.
Stainless steel pipe to feed the water bowl, removable and autoclavable.
Has a debris lter easy to clean and disinfection.
Valve for water regulation in the tub and glass feeder.
* Electrical commands with timer for activating the water in the tub and glass feeder and
* Electrical controls for Bio-System drive and water heating in the triple syringe.
Automatic selection of tips through individual pneumatic valves, allowing light handling.
Suckers with automatic individual drive easy to use, they provide an excellent operating
performance, allow professionals to work with better visualization of the operative eld and
reduce the risk of contamination by aerosol and greater patient comfort.
* High power electric Suckers with individual low voltage drive, provide lightness and
accuracy in the drive.
* Triple syringe swivel spout, removable and autoclavable.
* Arm Reach: terminal support with wide horizontal movement that enables optimal
approach to the surgical eld and excellent accessibility to the various resources available.
Optimizes work prioritizing the ergonomics and biosafety.
Translucent water tanks for syringe * and * spray tips and chlorinated water * Bio-
System.
ISO 9001 and ISO 13485 Quality system, ensuring that products are manufactured
within standard procedures.
Products manufactured according to the RDC 16/13 - National Health Surveillance
Agency – ANVISA resolution.
Description of Equipment
*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.
* Optional
IDENTIFICATION OF EQUIPMENT

6
*Bicarbonate jet SET/ Hand Jet
Product Features:
See Owner's Manual – Hand jet
- Shows the elapsed time and the end of the operation.
- No special optical lters.
- Low power consumption.
- 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.
IDENTIFICATION OF EQUIPMENT
* Optional

77
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.
B
C
A
19
20
24
25
21 22 23
01 - Triple syringe
02 - Access Cover
03 - Front Handle
04 - Vacuum pump sucker
05 - Venturi type sucker
06 - Arm reach
07 - Sucker Filters
08 - Bio-System tank
09 - Water tank
10 - Bowl water drive
11 - Syringe water heating
drive
12 - Glass Water supply
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
13 - Bowl
14 - Drain cover
15 - Water tank tubing
16 - Glass feeder
17 - Glass feeder tubing
18 - Cabinet body
19 - Bio-System Drive
20 - Adjust water ow for Glass feeder
21 - Adjust water ow for the bowl
22 - Water selector valve - tank / network
23 - Master valve - releases / blocks water ow
24 - Quick coupling for air outlet
25 - Quick coupling for water outlet
26 - Optical Sensor
*
13
14
10
11
12
07
09
08
B
C
16 15
17
18
26
01
03 A
06
02
04
05
Unit without coupling arm reach
"Tips support embedded in the unit”
* Optional

8
0807 09
04
03
05 06
01 02
10 11 12
13 14 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 + 3 teeth tip
03. Pedal tub water drive to actuate the water
supply to the bowl or to the glass feeder
04. Bicarbonate spray set (Hand jet)
05.Coupling arm reach for up to 5 tips
06.Coupling arm reach for up to 3 tips
07. Triple syringe with fully metal body or
injected thermoplastic handle "optional heater
set"
08.Triple syringe with fully injected
thermoplastic body "optional heater set"
09.Optical sensor to actuate the water supply
to the bowl
10.Suckers:
Venturi sucker
Large sucker for Vacuum Pump
Small sucker for Vacuum Pump
Cleaning brush sucker
Cannula sucker
Note: Suckers available with all-metal body
11.Bio-System Drive
12.Water selector valve - tank / network
13.Master Valve (system that allows cutting the
ow of water and air to the ofce.)
14.Intra oral Camera set
15. Water bowl manufactured with injected
material
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
The drawing illustrates
all optional items (page
08). Therefore, your
equipment will consist
only of the chosen items
selected during your
purchase option.
The use of any part,
accessory or material
not specied or provided
in these instructions is
of entire responsibility of
the user.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
* Optional

10
Units may be made composed by :
Optional Acronyms
1 BV sucker TBV
1 Venturi sucker TV
1 Venturi sucker + 1 BV sucker 2T
2 Venturi suckers 2 TV
2 BV suckers 2T BV
1 Syringe + 1 Venturi sucker S TV
1 Syringe + 1 BV sucker S TBV
1 Syringe + 1 Venturi sucker +1 BV sucker 3T
1 Syringe + 2 Venturi sucker 3T V
1 Syringe + 2 BV sucker 3T BV
1 Syringe + 1 Photo +1 Terminal High Speed + 1 Terminal micro motor
+ 1 Venturi sucker 5T
1 Syringe +1 Photo + 1 Terminal High Speed + Terminal micro motor +
1 BV sucker 5T BV
Curing Light OPTI
Arm reach ALC
Intra Oral Camera CAM
Complete equipment FULL
Identication label "responsible eld to identify
the product conguration."
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION

1111
TECHNICAL SPECIFICATIONS
Power Supply
Other specications
General
Technical features of the Delivery Unit and its accessories
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)
Inlet air pressure
60-80 PSI ±2
Voltage in equipment (coming from dental chair)
12V~ e 24 V~
Net weight (complete version)
15 Kg
Gross weight (complete version)
21 Kg
Venturi suction system – Maximum vacuum
220 mm/Hg
Venturi suction system – Volumetric displacement
30 l/min
Capacity of water reservoir (Water / Bio-System*)
1000 ml* ou 800 ml*
Power
5,2VA
Light source
1 LED
Active medium
Semicondutor Led (InGaN)
Specications of Curring Light
* Optional

12
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
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.
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.
Use of different cables, transducers and accessories from those specied may result
in increased emissions or decreased immunity of the equipment.
TECHNICAL SPECIFICATIONS

1313
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.
TECHNICAL SPECIFICATIONS
Electromagnetic Emissions

14
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
TECHNICAL SPECIFICATIONS
Electromagnetic Emissions

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)
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.
TECHNICAL SPECIFICATIONS
Electromagnetic Emissions

16
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Equipment with coupling "reach arm"

1717
TECHNICAL SPECIFICATIONS
Dimensions (mm)
Equipment without coupling "reach arm "

18
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.
B type equipment
Product symbols
TECHNICAL SPECIFICATIONS
High-speed with FO
Curring Light
Triple syringe
BV ejector
Ejector type Venturi
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.
Packing symbols
Bicarbonate Jet
Water heating activation
Warning - Consult the manual

1919
TECHNICAL SPECIFICATIONS
Bowl’s water ow
Key switch water supply
network/reservoir
Bowl water flux
regulation
Master valve (key for water cut)
Cup holder water ux
regulation
Cup lling
Product symbols
Content of accessible and non-accessible demarcations
INSTALLATION OF EQUIPMENT
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).
- 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.
Bio-System.
Authorized representative
in the European Community

20
EQUIPMENT OPERATION
Control Panel
Water supply to the bowl is driven by the "optical sensor *"
*
*
*01 - Water triggering in the Bowl
02 - Water triggering in the cup holder
03 - Water triggering heating syringe
WARNING:
To set the time of water ux in the cup holder,
press the "water in the cup holder" button (02)
for 3 seconds (it will produce a long beep and the
LED will ash).
Upon reaching the desired time, press again
the button "Water in the cup holder" (02). The
ux time is recorded. To set the time of the water ux in the bowl, press the "Water in the
bowl" button (01) for 3 seconds (it will produce one long beep and the LED will ash). Upon
reaching the desired time, press again "Water in the Bowl" (01). The ux time is recorded.
The settings "Water in cup holder" and "Water in the bowl" have a water ux timeout, 1
minute for the water in the cup holder and 4 minutes for the water in the bowl.
When turning the key "triggering heating water syringe" (03), the LED will turn on (A)
starting the heating of syringe water. The temperature must remain around 40º C. To turn
off the "trigger water heating", press (03) again.
A
01 0203
Water supply is done automatically through the optical sensor (B) by simply approaching
the patient, providing greater convenience in operation.
The water unit is designed in order to meet the
left or right hand users, with ease of installation
of the "optical sensor set" on both sides, without
loss of functionality in any case. At the time of
installation by authorized technician from Gnatus,
inform desired position (right or left handed). He
will make necessary adjustments.
Optical sensor positioning for right or left-
handed B
The ejectors (both BV and Venturi) start
working automatically when retired from the
tips support the BV ejectors feature suction ow
adjustment , and its regulated moving the lever
located at the ejector up or down.
Ejectors operation
* Optional