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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

The

recommended

power

supply quality is the same as
used

for

commercial

or

hospital environment. If is
required a continuous use
during energy supply outages,
it is recommended that the
equipment be feed by an
uninterruptible power supply
or a battery.

If an image distortion occurs,
may be necessary place the
equioment far from the supply
frequency

or

to

installa

magnetic

armour.

The

frequency magnetic field shall
b e

m e a s u r e d

a t

t h e

installment place to assure
that it is low enough.

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 5 cycles

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 5 cycles
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

U

t is the a.c. power supply voltage before the application of the test level

Floors should be wooden,
concrete or ceramic. If the
floor

is

covered

with

synthetic

material,

the

relative humidity should be
at least 30%

It

is

advisable

that

the

quality of the power supply
should be that of hospital or
t y p i c a l

c o m m e r c i a l

environment

It

is

advisable

that

the

quality of the power supply
should be that of hospital or
t y p i c a l

c o m m e r c i a l

environment

TECHNICAL SPECIFICATIONS

Electromagnetic Emissions

Summary of Contents for Syncrus G3

Page 1: ......

Page 2: ... 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 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 f...

Page 3: ...nsitivity 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 o...

Page 4: ...rofessional 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 Identification Technical Name Odo...

Page 5: ...rative field 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 field and excellent accessibility to the variou...

Page 6: ...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 comp...

Page 7: ...7 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 flow for Glass feeder 21 Adjust water flow for the bowl 22 Water selector valve tank network 23 Master valve releases blocks water flow 24 Qui...

Page 8: ...8 08 07 09 04 03 05 06 01 02 10 11 12 13 14 15 MODULES ACCESSORIES OPTIONS AND MATERIALS OF CONSUMPTION ...

Page 9: ...ter 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 flow of water and air to the office 14 Intra oral Camera set 15 Water bowl manufactured with injected materia...

Page 10: ... 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 Identification label responsible field to identify the product configuration MODULES...

Page 11: ... 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 Ac...

Page 12: ...ment 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 Eletro...

Page 13: ...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 equat...

Page 14: ...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...

Page 15: ...ransmitter 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 Howeve...

Page 16: ...16 TECHNICAL SPECIFICATIONS Dimensions mm Equipment with coupling reach arm ...

Page 17: ...17 17 TECHNICAL SPECIFICATIONS Dimensions mm Equipment without coupling reach arm ...

Page 18: ...ICATIONS 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 st...

Page 19: ...stallation 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...

Page 20: ...older 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 02 03 Water supply is done automatically through the optical sensor B by simply approaching the patient providing greater convenience in ...

Page 21: ...be controlled by the operator with more or less pressure on the pedal lever A Progressive pedal fig 01 For the operation of rotary instruments remove support the instrument to be used actuate on the foot control C Progressive pedal with water blocking system for hand pieces fig 02 For the operation of rotary instruments remove support the instrument to be used actuate on the foot control C To actu...

Page 22: ...C A Coupling of tube The curve of the coupling of the cannula was designed for better handling but can also be cut at the location indicated with the aid of a knife Use of 3 Way Syringe Press button A for water to come out B for air to come out or both simultaneously to obtain a spray Water Heating When you turn on the key hot water activation D LED will light C starting to heat water from the syr...

Page 23: ... perform restorations in incremental layers with a maximum thickness of 2mm 04 06 03 01 02 WARNING Never aim the blue light beam towards the eyes Use the eyesight protection 04 In order to protect the eyes the eyesight protection 04 filters only the blue light used for the resins polimerization and it allows ambient light to pass through Water flow adjustment 01 Cup filler adjustment 02 Bowl flush...

Page 24: ... a solution of chlorine at 500 p p m is prepared How to prepare the solution Take 25ml of hypochlorite of sodium at 1 and dilute it in 500 ml of water 1 to 20 Such solution should be prepared daily IMPORTANT Follow this proportion strictly to avoid damages in the equipment and to have an efficient result in the disinfection A B Bio System Remove hanpieces from terminals Take terminals to bowl or w...

Page 25: ...at it is maintained stored as mentioned in this instruction of use Thus the equipment will not lose or alter its physical and dimensional features The equipment has been planned not to be sensitive to interference such as magnetic fields external electrical factors electrostatic discharge pressure or variance of pressure provided that the equipment is installed maintained clean preserved transport...

Page 26: ...asons and circunstances Therefore here are some important reminders for your daily routine Try to follow these simple rules which will save you a lot of time and will avoid unnecessary expenses once they start making part of your working procedure Gnatus shall not be responsible for Use of the equipment differing from that for which it is intended Damages caused to the equipment the professional a...

Page 27: ...its composition Bicarbonate Jet For further information please see the Jet Hand manual which comes with the product Precautionsandwarningsduringthe cleaninganddisinfection of equipment If the equipment has any abnormality check if the problem is related to any item listed in the topic of unforeseen events failures causes and solutions If it is not possible to resolve the problem turn off the equip...

Page 28: ... the liquid does not enter into the unit The application of other solvent based cleaning products or sodium hypochloride isn t recommended because they may damage the equipment This product can also be used for cleaning and disinfection of the water tank unit NOTE The registration at the Ministry of Health of the BactSpray is executed separately from the product described in this manual as the Bac...

Page 29: ... days in order to remove accumulated residues Composition Active Drug Phosphoric Acid 13 6 Excipients Isopropyl Alcohol Acidulant Dye and Thickener Warning do not use foaming product NOTE The registration at the Ministry of Health of the Sugclean is executed separately from the product described in this manual as the Sugclean is not manufactured by Gnatus CAUTION For internal cleaning of Suction p...

Page 30: ...h up to clean it If you want additional information regarding cleaness please look at the instructions from the product Cleaning of the drain Pull the drain 03 with a tweezer clean and disinfect it Warning Always use protection gloves when manipulating filters and drainages Discard waste and contaminated products in biological waste containers CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION...

Page 31: ...fer routinely measurements following the current legislation of the country But never with a period superior to 3 years For protecting your equipment look for a Gnatus technical assistance for periodic reviews as preventive maintenances Preventive Maintenance Gnatus states that the supplying of the circuits diagram Part lists or any other information that permits the technical assistance by the us...

Page 32: ...servoir run out of water Compressor disconnected Put filtered water in reser voir Plug compressor in Bowl s water flow and cup filling are not operating Lack of water Water valve is closed Power cut Chair fuse burned Chair s main switch is off or terminal box is disconnected Check the water supply Open the water valve Check the energy supply Turn off the chair from mains power and request a Techni...

Page 33: ...pment s not working Power cut Chair s fuse burned Check power supply Turn off the chair from mains power and request a Technician presence Equipment is not polymeri zing resins Resin is not appropriate for LED s photopolymerizer wave length range Resin residues in light cable Get the indicated resin for the photopolymerizer s wave length range one with con tains photoinitiators based on camphorqui...

Page 34: ...ntion to our authorized resellers chain Only this chain will keep your equipment constantly new because it has trained technical assistant and specific tools for the correct maintenance of your device Whenever you need demand the presence of a Gnatus technician from the nearest resale or ask through the Attendance Service GNATUS 55 16 2102 5000 SAC 0800 7015 054 FINAL CONSIDERATIONS EQUIPMENT S WA...

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