Gnatus Syncrus G8 H User manual

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PRESENTATION OF MANUAL

INSTRUCTIONS FOR USE

EQUIPMENT:

Technical Name: Dental Delivery Units and Accessories Trade Name: Syncrus G8 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.

INDEX

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

IDENTIFICATION OF EQUIPMENT .................................................................05

- Principles and bases applied to the functioning of the product..............................06

- Description of Equipment ...............................................................................06

- Indication of Equipment ................................................................................07

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....08

TECHNICAL SPECIFICATIONS .......................................................................11

- Technical features of the Delivery Unit and its accessories ...................................11

- Electromagnetic emissions ..............................................................................13

- Dimension ....................................................................................................17

- Symbologies of packaging .............................................................................18

- Symbologies of product .................................................................................18

- Standards applied .........................................................................................20

- Content of acessible and non-accessible demarcations .......................................20

INSTALLATION OF EQUIPMENT ....................................................................20

OPERATION OF EQUIPMENT .........................................................................20

- Turning on / off the dental set .........................................................................20

- Positioning ...................................................................................................21

- Activation of Terminals ..................................................................................21

- Adjustment of Spray “TB/TM” ........................................................................21

- Adjustment of Spray “FO/MME” .......................................................................21

- Use of 3-Way Syringe ...................................................................................22

- Curing Light Activation ..................................................................................22

- Laser Hand Activation ...................................................................................23

- Ultrasound Activation .....................................................................................24

- Bicarbonate Jet Activation"Jet Hand" ................................................................25

- Equipment activation by the delivery unit panel .................................................27

Use and applications (Digital control panel kit) ..................................................28

- How to supply the reservoirs ...........................................................................29

PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................30

- Conditions of transport, storage and operation ..................................................30

- Sensitiveness to environmental conditions foreseeable in normal situations of use .30

- Precautions and warnings “during the installation” of equipment ..........................30

- Recommendations for preserving the equipment. ...............................................31

- Precautions and warnings “during the use” of equipment ....................................31

- Precautions and warnings “after” the use of equipment ......................................31

- Precautions and warnings during the “cleaning and disinfection” of equipment .......32

- Precautions in case of alteration in the functioning of equipment ..........................32

- Precautions to be adopted against foreseeable or uncommon risks,

related to the deactivation and abandoning of equipment ......................................32

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............33

- Additional procedures for reuse .......................................................................33

- Cleaning ......................................................................................................33

- Disinfection ..................................................................................................33

Cleaning: ......................................................................................................34

- Ultrasound ...................................................................................................34

INDEX

- Laser Hand ...................................................................................................34

- Bicarbonate Jet .............................................................................................35

- Reservoirs ....................................................................................................35

- Bio-System ..................................................................................................35

- 3-Way Syringe ..............................................................................................35

- Preventive Maintenance .................................................................................36

- Corrective Maintenance ..................................................................................36

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................36

WARRANTY OF EQUIPMENT ..........................................................................38

FINAL CONSIDERATIONS ..............................................................................38

DESCRIPTION OF THE 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.

Identi cation

Technical Name: Dental Delivery Units and Accessories

Trade Name: Syncrus G8 H Delivery Unit

Brand: GNATUS

kit Laser Hand Identi cation

Trade Name: Kit Laser Hand Nº Registro Anvisa: 80051420005 Brand: MM Optics

DESCRIPTION OF THE EQUIPMENT

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.

Description of Equipment

Equipment for odontological use, ﬂ ex type model, coupled to the chair.

Equipped with side panel and central control.

Flexible, removable and autoclavable tips support, protecting them against impact.

Tips movement through retractile rods with lock for tension release of the hose that provides lightness of movements, allowing greater proximity to operative ﬁ eld.

Articulated arms with wide horizontal and vertical movement, with pneumatic locking, triggered by button located under the equipo body, providing gentleness of movement and stop at the desired position. Frontal bilateral catcher easily accessible, with distinctive design.

Non-removable auxiliary tray support with horizontal movement, designed to adapt to the various trays and instruments supports available in the market (items not supplied by Gnatus).

Equipo body built of high impact polyethylene.

Steel structure with surface treatment using nanotechnology. High brightness ﬂ at paint, epoxy-based, polymerized in a 250° C heater, resistant to corrosion and cleaning materials.

Smooth hoses, without grooves or ridges, rounded, soft and ﬂ exible.

EN ISO 9001/2000 and EN ISO 13485/2003 Quality System, assuryng the products are manufactured under standart procedures.

Products manufactured in agreement with RDC 59/00 - ANVISA - (Sanitary Surveillance National Agency).

Curing light (optional item) – Features of the product:

The Curing Light belongs to the newest generation of LED photo-activation devices. This abbreviation stands for Light Emitting Diode, a totally different type of light emission, if compared to conventional halogen equipment.

Unlike traditional devices, which generate wide-spectrum light and heat, this technology uses a cold light of the precise wave length needed to activate various dental products.

LED technology, which was recently introduced in Dentistry, brought about several useful features to those light-curing devices used in composite resin restoration. Besides being more durable, LED technology turned devices more compact, ergonomic and easier to install and transport. The emission of cold light within a precise wave length range ensures the safe cure of camphorquinone-activated composites, preventing dental heating, pulp damage or discomfort for both patient and dentist. Although being relatively new, this technology is nowadays in its second generation. LED safety and efﬁ ciency, now allied to high-energy emission, are available to all clinic procedures which require light-curing power, including bleaching treatments.

The light of 440nm-460nm wave length, allied to the high energy emitted by Curing Light, makes possible the multi-functionality of this device:

- Direct restoration procedures: composite resins, ionomers and adhesives.

- Indirect restorations: adhesive cementation of laminates, inlays, esthetic pins and

metal-free crowns.

- Dental Bleaching: activation of bleaching gel and polymerization of gingival barriers.

Compatible with 35% hydrogen peroxide-based bleaching gels.

DESCRIPTION OF THE EQUIPMENT

- Attachment of braces and orthodontic accessories.

- Activation of light-cure materials, such as sealants, surgical cements and covering

bases.

Designed and built with cutting-edge technology, it meets the highest standards speciﬁ ed

by world’s dental authorities.

Operation control display in handpiece, sound alarm with beep every 10 seconds and

4 beeps at the end of the cycle.

Advantages offered by Curing Light:

- More spectrally-selective light than conventional lamps.*

- Cold light, it doesn’t heat up the resin nor the tooth**

• Light compact equipment that provides handling comfort.

• Low power consumption.

• Longer useful life of the light emitting diode (equivalent to 36.000.000 cycles of 10

seconds).

• It does not use optical ﬁ lter.

• It does not require forced ventilation, thus avoiding noise emission.

We noted that the light emitted by the Curing Light is completely contained within the absorption interval of the photo starter, therefore it’s 100% used, whereas the conventional equipment running on halogen lamps has non-used wave-length regions.

The Curing Light doesn’t generate heat since it uses light emitting diodes.

The light conductor is removable, made out of high resistance polymer and of easy maintenance.

Laser Hand Kit (optional item) – Features of the product:

See the Owner’s Manual - Laser Hand

Digital control panel Kit (optional item)

Additional information: See “Digital control panel” Owner Manual (“Bien Air”)

Bicarbonate jet (optional item) – Features of the product:

See the Owner’s Manual - Jet Hand

Indication of Equipment

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

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

The content on this page is informative; the equipment can be different from those illustrated. Therefore, when purchasing the product check the technical compatibility between equipment, coupling and accessories.

A B

A - Power (power ul trasound

adjustment) B - Speed (electric microengine power

adjustment) C - Light (electric microengine

brightness adjustment)

Basic product conﬁ guration:

1- Triple Syringe, 2- High speed TB/TM/FO terminals, 1- Micro engine terminal TB/TM/ FO/MME.

01 - Triple Syringe 02 - Bilateral Catcher 03 - Negatoscope 04 - Control Panel 05 - Auxiliary trays 06 - Gauge

07 - Articulated arm 08 - Column Arm

09 - Terminal microengine

10 - High rotation terminals

11 - Auxiliary tray / Support tools (not supplied by Gnatus) 12 - Water records for FO/MME/Ultrasound 13 - Arm brake valve

optional item

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

01 02

The drawing illustrates all optional items; therefore, your equipment will consist only of items selected during your purchase option.

;;

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

01 - Terminals

- TB: Borden Terminal

- TM: Midwest Terminal

- FO: Optical ﬁ ber Terminal

- MME: Electric microengine Terminal

02 - Photopolymerizes + tip for 3 teeth

03 - Laser hand Kit

(No registration Anvisa 80051420005)

- Laser Hand

- "patient and professional" protection goggles

- Manuals 04 - Bicarbonate jet "Jet Hand" Kit

- Bicarbonate Jet

- Plunger

- Reservoir caps

- Sealing Rings

- Bicarbonate Sachet

- Manual

05 - Ultrasound kit

- Ultrasound

- Grip key

- Inserts "no. 1, 2, 10P and A120 "

06 - Digital control panel MME Bien Air Kit

- Digital control panel

- Electric micro-engine

- Contra Angle 1:1

- Contra Angle 1:5

- Manual

07 - Water Heater Kit for triple Syringe

The use of any part, accessory or material not speciﬁ ed or provided in these instructions is of entire responsibility of the user.

The accessories described above can never be commercialized separated from the product.

TECHNICAL SPECIFICATIONS

Technical features of the Delivery Unit and its accessories General

Model Syncrus G8 H Delivery Unit Classiﬁcation of Equipment as per ANVISA: Class II Classiﬁcation of Equipment as per standard IEC 60601-1: Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1) Degree of safety of application in presence: Equipment not suited to an anesthetic mixture inﬂammable with air, oxygen or nitrous

oxide. Mode of Operation Continuous operation with intermittent load

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 80 PSI (5,52 BAR) Inlet air pressure - Syringe 40 PSI (2,76 BAR) Maximum consumption of air (dental set) 80 l/min Capacity of water reservoir 1000ml High rotation air consumption 9 l/min

3333

TECHNICAL SPECIFICATIONS

High rotation water consumption 0,02 l/min Syringe air consumption 17 l/min Syringe water consumption 0,1 l/min Maximum capacity of load applied to trays 1Kg Net weight (complete version) 26 Kg Gross weight (complete version) 31 Kg

Dimensions (mm) - Auxiliary trays

385 x 300

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

TECHNICAL SPECIFICATIONS

Speci cations of Ultrasound

Frequency of Vibrations of Ultrasound 29,000Hz Consumption of irrigating liquid 28 ml/min Power consumed 15VA ±10% Transducer system Piezoelectric ceramic

The materials used to produce the equipment are Biocompatible.

Electromagnetic Emissions

3535

TECHNICAL SPECIFICATIONS

Electromagnetic Emissions

TECHNICAL SPECIFICATIONS

Electromagnetic Emissions

3737

TECHNICAL SPECIFICATIONS

Electromagnetic Emissions

Use of different cables, transducers and accessories from those speciﬁ ed may result in increased emissions or decreased immunity of the equipment.

List of pieces and circuit scheme

Gnatus Company declares that the supply of the circuit scheme, list of pieces or any other information that propitiate technical attendance for the user, can be request if there is an agreement between the user and Gnatus Company.

TECHNICAL SPECIFICATIONS

Dimensions (mm)

3939

TECHNICAL SPECIFICATIONS

Packing symbols

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).

Product 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.

Packing to be transported and / or stored avoiding humidity, rains and wet ﬂ oor.

The packing must be stored and transported away from direct sun light exposure.

Temperature limit for the packing to be stored or transported.

Turned on position

Turned off position

B type equipment

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.

It determines to spitting position / last position.

Lift seat.

Lower seat.

Lift backrest.

Lower backrest.

TECHNICAL SPECIFICATIONS

Product symbols

It determines the initial position.

It determines the work position “1”.

If determines the work position ”3”.

Bicarbonate Jet

Warning - Consult the manual

X ray view operation

Dental Light

Curring Light

Authorized representative in the European Community

If determines the work position ”2”.

If determines the work position ”4”.

Laser Hand

Electric low-speed-motor rotation inverter

Bio-System operation

High-speed with FO

Triple syringe

Cup ﬁ lling

Bowl’s water ﬂ ow

Ultrasound

Emergency stop

Electric low-speed-motor

3;3;

TECHNICAL SPECIFICATIONS

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.

Content of accessible and non-accessible demarcations

INSTALLATION OF EQUIPMENT

The installation of this equipment requires specialized technical assistance (Gnatus).

OBS: These information also make part of the Manual of Installation and Maintenance of the equipment that can be found with the authorized Gnatus technician.

- 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.

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.

OPERATION OF EQUIPMENT

Positioning

The arm “item 07, page 08” has horizontal and vertical movements, with a pneumatic locking device.

Maintaining the button “Arm break valve” (13) pressed, place the delivery unit in the desired position holding it by the handle, and release it to fasten it in this position.

Activation of the Terminals

For the functioning of the rotating instruments remove from the support the instrument to be used, trigger the control pedal moving the lever (A) with the feet.

The power (air supply) can be controlled by the operator with higher or lower pressure on the pedal lever (A).

Chip Blower System:

The "chip-blower" system allows the release of the airﬂ ow with the stopped turbine (air function).

Pressing the (B) key downward, air will trigger on the tips.

Pressing the key (B) downward and moving the lever to the right (A) together, it will trigger the high speed air turbine and water (spray).

Adjustment of Spray of “TB/TM high and low rotation terminals”

The adjustment is made via a valve positioned in the terminal. Turn it in a clockwise direction to reduce the spray and in a counter- clockwise direction to increase it.

Note: As the “TB” double terminal does not have a spray this adjustment is not required.

Adjustment of Spray of “MME/FO high and low rotation terminals”

The adjustment is made via the valves positioned under the box of the delivery unit (C). Turn it in a clockwise direction to reduce the spray and in a counterclockwise direction to increase it.

4343

OPERATION OF EQUIPMENT

Retractable rods with lock

Pull the rod smoothly until the lock is activated automatically. In order to withdraw the rod, pull it again until the lock is released.

Note: The syringe rod does not have a lock.

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 syringe. Temperature should remain about 40 °C. To turn off the "water heating activation" function, press key (D) again.

Curing Light Activation

Select application time, press time selection button (01), which values are: 10s (standard mode), 20s, 60s, 80s and 90s. To initiate a polymerization cycle, press the timer trigger (02), which generates a short beep every 10 seconds and a 4 beeps at the end of cycle.

To interrupt a polymerization cycle just activate the timer trigger again (02).

IMPORTANT:

Keep the light conductor tip (03) at least 2mm away from the restoration.

OPERATION OF EQUIPMENT

Keep the light conductor (03) always protected by an expendable PVC ﬁ lm, which must be changed for every patient. This procedure protects the light conductor from scratches and other residues.

Use the polymerization time recommended by the compound resin manufacturer and always perform restorations in incremental layers with a maximum thickness of 2mm.

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) ﬁ lters only the blue light used

for the resins polimerization, and it allows ambient light to pass through.

Laser Hand

The “Laser Hand Kit” is low intensity (780nm) and provides relief of acute and chronic pain, and speeds repair of damaged tissue by means of biostimulation effects of radiation.

Eminently analgesic, anti-inﬂ ammatory and biomodulation effect.

• Inﬂ ammations;

• Oral mucous lesions;

• Dental hypersensitivity;

• Analgesia;

• Paresthesia;

• Alveolitis and pericoronitis;

• Acceleration of post surgical and injury cicatrisation;

• Decrease of edemas, bruising and scabbing;

• Distension, muscular spraining and articular pain;

• Acupuncture (optional).

Activation of the “Laser Hand”

Turn on the main unit power switch, which will

automatically turn on the laser.

To select application time, press the time selection

button (01) with variations of: 01s to 90s. Maintain pressure on the key until desired time selection, which can be at 1-second intervals (1s, 2s, 3s, 4s, 5s, 6s, 7s...) or 10-second intervals (10s, 20s, 30s, 40s, 50s..).

To start, press timer activation button (02). A

single beep will be heard, followed by 5 beeps at each conclusion.

The laser will remain active with a 10-minute

program. After 10 minutes, a beep will inform that the laser is in standby mode.

To restart the cycle, press the key (02) which will

sound 2 beeps and the last programmed selection will appear on the screen. To interrupt the cycle, press button (02).

Note: For a new program, in case desired time is less than the previous program, press (01) until the start of time “00”.

WARNING: Never direct the red light towards eyes;

4545

OPERATION OF EQUIPMENT

Ultrasound Trigger

Remove the ultrasound hand piece from the holder; Choose the appropriate insert for the wanted operation according to "Techniques and

Applications";

Screw the chosen insert in the hand piece with the aid of clamping key (01) and a small

grip;

Trigger the control pedal shifting the lever with the feet (02) and place the selector

power (03) in accordance with the sensitivity of operation.

Adjust the water ﬂ ow through the record (04) located at the inferior part of the equipo. At the end of the procedure release the lever from the pedal, letting it return to its

original position. Place the hand piece in the holder.

Function available at the side panel when the equipo presentes ultrasound in its conﬁ guration.

IMPORTANT RECOMMENDATION

The shape and the weight of each insert are important facts to obtain a maximum performance of the generator of ultrasounds, the operator attention to these two characteristics, will assure the maintenance of the best performances of the units, however, we recommended that the structure of the insert is not altered (limiting it or twisting it), in the same way the aging of an inserted drives to an alteration of its original characteristic, becoming it ineffective.

Any insert that has been damaged by use or accidental impact should be changed.

OPERATION OF EQUIPMENT

Bicarbonate Jet "Jet Hand"

For further information, please see the Jet Hand manual which comes with the product.

Technical and applications

All the inserts of the Ultrasound have the particularity of vibrating in an only plane (front vibrations to back, and in the axis of the insert).

The lateral vibrations common to other destartarizators don’t exit, the rectilinear displacement favors more precise approach of the tooth and of the gum.

The enamel and the cement are protected of the inutile shocks.

Inside of this main plane of vibration, the end of each insert is driven by small vibratory movements.

To abtain the maximum performance ot the Ultrasound the operator should pay attention to the speciﬁ c vibrations regulations of each insert.

Periodontics

Insert Nº 1 “Removal of supragengival calculus”

Tip Nº1 is used for lingual, buccal and approximal supragingival scaling. Recommended for the removal of gross calculus. Recommended power setting: 10-50%.

Insert Nº 2 “Removal of supragengival calculus”

Tip Nº2 is used for lingual and buccal supragingival scaling. Recommended for the removal of gross calculus. Recommended power setting: 10-100%.

Insert Nº 10-P “Universal”

Tip 10-P is used for lingual and buccal supragingival scaling. It’s one of the most popular Tips and is recommended for the removal of heavy calculus. Recommended power setting: 10-70%.

Insert Nº H-3 “Universal”

Tip H-3 was designed for subgingival scaling and can also be used on furcations. Recommended power setting: 10-70%.

(it comes with the Ultrasound kit)

(optional item)

Endodontia

Insert Nº ET-20 “Preparation of canal”

Tip ET-20 is used in the pulp chamber for removing pulp stones, dentin and old ﬁ llings. Length: 17 mm. Recommended power setting: 10-25%.

(optional item)

4747

OPERATION OF EQUIPMENT

Endodontia

Insert Nº ET-40 “Preparation of canal”

Tip ET-40 is used in the coronal and apical part of root canals. Among other things the tip can be used to remove posts, widen calciﬁ ed canals and remove hard ﬁ llings. Length: 24 mm. Recommended power setting: 10-15%.

Inserto Nº S-04 “Preparation of canal”

Tip S-04 is made of titanium and has no diamond coating. Its primary area of use is the isolation and removal of broken instruments. Length: 24 mm. Recommended power setting: 10-15%.

Insert Nº S12-90 “Apical surgery”

Tip S12-90 is angled at 110° and is used in combination with the instrument holders A-120 and A-90 With the aid of the instrument holder, the S12-90 can be precisely positioned at the angle needed for the treatment. Recommended power setting: 10-50%.

Insert Nº P-14 “Apical surgery”

Tip P-14 is angled at 100° and it’s also used in combination with the instrument holders A-120 and A-90. It has a slimmer design and is therefore better suited for small roots. Recommended power setting: 10-50%.

Insert Nº A-120 “Removal of broken instruments”

Tip A-120 is a holder for ﬁ les and instruments with a diameter of

0.8 mm. It can be used with implant tips and AP tips. A-120 has an angle of 120°. Recommended power setting: 10-50%.

Insert Nº A-90 “Removal of broken instruments”

Tip A-90 is a holder for ﬁ les and instruments with a diameter of

0.8 mm. It can be used with implant tips and AP tips. It has an angle of 90°. Recommended power setting: 10-50%.

(optional item)

(it comes with the Ultrasound kit)

(optional item)

Dentistry and Prosthesis

Insert Nº 5-AE “Removal of posts and crowns”

Tip 5-AE is used for removing crowns and inlays. Its small diameter enables access to difﬁ cult-to-reach areas. Recommended power setting: 10-100%.

Insert Nº 6-A “Amalgam condensation”

Tip 6-A is used for amalgam condensation. Recommended power setting: 10-50%.

(optional item)

OPERATION OF EQUIPMENT

Equipment activation by the delivery unit panel

Description:

01 - X ray view operation 02 - Activation of the dental light 03 - Initial position 04 - Work position “1” 05 - Work position “2” 06 - Work position “3” 07 - Work position “4” 08 - Spitting position / last position. 09 - Bowl’s water ﬂ ow 10 - Cup ﬁ lling 11 - Bio-System operation 12 - Emergency stop 13 - Rise seat 14 - Lower backrest 15 - Rise backrest 16 - Lower backrest 17 - Electric low-speed-motor rotation inverter

Available in equipment conﬁ gured with electric micromotor.

Warning:

To preset the cup ﬁ lling time, press the “Cup ﬁ lling” key (10) for 3 seconds (a long beep will be heard and the LED will keep blinking).

When the desired time is reached, press the “Cup ﬁ lling” key again. The cup ﬁ lling time is then set.

To preset the bowl’s water ﬂ ow, pres the “Bowl water” key (09) for 3 seconds (a long beep will be heard and the LED will keep blinking).

When the desired time is reached, press the “Bowl water” key again. The cup ﬁ lling time is then set.

The “Cup ﬁ lling” and “Bowl water” time functions have a limited preset ﬂ ow time, 1 minute for the cup ﬁ lling and 4 minutes for the bowl’s water ﬂ ow.

When the key “Last position/Spitting position” (08) is pressed, the dental light will go off (if it was on), the bowl will drain (for the preset time, and if it was not programmed yet, for four minutes) and the backrest will go up to the spitting position. When pressed again, the backrest will return to the last position and the dental light will go on (if it was on).

After pressing the “Last position/spitting position” key (08), any other operation will trigger the “Stop”, and automatically the backrest current position will be deﬁ ned as “Last position”.

When the “Emergency stop” (12) key is pressed, the LED will be on and all chair movements are interrupted until pressed again (12).

It has 4 programmable working positions. To program, just position the chair and the reﬂ ector at the desired intensity and keep the chosen working position key pressed for 3 seconds, the chair will produce a long bip determining that the position was already programmed.

* optional

4949

OPERATION OF EQUIPMENT

Use and applications (Digital control panel kit)

To turn on the “Optima MX int”, just take out the electric micromotor terminal from the support where it is coupled and chose the operation option:

- Operative (contra angle 1:5);

- Endo (contra angle 1:1).

To turn off, put back the terminal to the equipment’s support.

OFF

Micromotor lever in initial position.

Micromotor lever turned to the front.

- Digital control panel with rotation system;

- High torque micromotor;

- Contra angle 1:1;

- Contra angle 1:5;

- Allows reduction of the number of instruments. It is possible to cover most operations with only two contra angles;

- Wide speed range (100 to 40.000 rpm with CA 1:1 and 500 to

200.000 rpm with CA 1:5);

- Maintains constant selected speed;

- 40 programs available (20 preset).

Rotation System;

OPERATION OF EQUIPMENT

How to provision the reservoirs

Water - Syringe / Handpieces

Remove the reservoir (01) uncoiling it on clockwise and make the replacement of water.

After the replacement put it back coiling on anticlockwise. Always use ﬁ ltered water or aseptic products.

Bio-System

Remove the reservoir (02) uncoiling it on clockwise and make the replacement. Use a chlorinated water solution 1:500.

Preparing the solution:

From a solution of hypochlorite of sodium at 1%, 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 efﬁ cient result in the disinfection.

0102

Supply through the Water Unit

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PRECAUTIONS, RESTRICTIONS AND WARNINGS

Transportation, storage and operation

This equipment must be transported and stored observing the following directions:

- Avoid falls and impacts;

- Keep it dry, do not expose it to rain, water drops or wet ﬂ oor;

- Keep it away from water and direct sunlight, and in it original wrapping;

- Don’t move it over irregular surfaces, protect it from rain and observe the maximum

stack quantity speciﬁ ed in the packaging;

- Transportation and storage temperature range: -12°C to 50°C.

- Ambient temperature range recommended by Gnatus +10 ° C to +35 ° C.

The Equipment maintains its condition of safety and efﬁ cacy, provided that it is maintained (stored) as mentioned in this instruction of use. Thus, the equipment will not lose or alter its physical and dimensional features.

Sensitivity to environmental conditions in normal situations of use

The equipment has been planned not to be sensitive to interference such as magnetic ﬁ elds, external electrical factors, electrostatic discharge, pressure or variance of pressure, provided that the equipment is installed, maintained, clean, preserved, transported and operated as per this instruction for use.

Precautions and warnings “during the installation” of quipment

- The equipment should only be installed by Gnatus authorized technical assistance or

technicians.

- Position the unit in a place where it will not get wet.

- Install the unit in a place where it will not be damaged by the pressure, temperature,

humidity, direct sunlight, dust, salts, or sulfur compounds.

- The unit should not be submitted to inclination, excessive vibrations, or blows (including

during transportation and handling).

- This equipment was not planned for use in an environment where vapors, anesthetic

mixtures inﬂammable with air, or oxygen and nitrous oxide can be detected.

- Before the ﬁ rst use and/or after long interruptions from work such as vacations, clean

and disinfect the equipment; eliminate air and water deposited in the internal hoses.

These information also make part of the Manual of Installation and Maintenance of the equipment that can be found with the authorized Gnatus technician.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Recommendations for the dental equipment maintenance

Your Gnatus equipment has been designed and developed according to the standards of modern techology. Similarly to other kinds of equipment, it requires special care, which is many times neglected due to several reasons 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.

Precautions and warnings “during the use” of equipment

- The equipment should only be operated by duly enabled and trained technicians (Dental

Surgeons, Capacitated Professionals)

- If any maintenance should be required, only use services of the Gnatus Authorized

Technical Assistance.

- The equipment has been manufactured to handle both continuous and intermittent

operation; so follow the cycles described in these Instructions for Use.

- Although this equipment has been planned in accordance with the standards of electromagnetic compatibility, it can, in very extreme conditions, cause interference with other equipment. Do not use this equipment together with other devices very sensitive to interference or with devices which create high electromagnetic disturbance.

- Do not expose the plastic parts to contact with chemical substances, use in the routines of dental treatment, such as: acids, mercury, acrylic liquids, amalgams, etc.

Bicarbonate Jet:

- It is not advisable to use this equipment in patients who have serious renal or respiratory alterations, or who undergo hemodialysis. These cases should be followed be followed by a doctor.

- We recommend the use of a mask and goggles for applying the bicarbonate jet.

- Avoid leaving sodium bicarbonate in the container for long periods without use.

The effect of residual humidity in the air may alter the properties of the powder and

cause blocking.

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 and/or the patient by the incorrect installation and erroneous procedures of maintenance, differing from those described in these Instructions for use which come with the equipment or by the incorrect operation of it.

Precautions and warnings “after” the use of equipment

- Turn off the main switch of the dental set when it is not in use for an extended period

of time.

- Always maintain the equipment clean for the next operation.

- Do not modify any part of the equipment. Do not disconnect the cable or other

connections without need.

- After using the equipment, clean and disinfect all the parts which may be in contact

with the patient.

- Upon noticing irremovable stains, splits or cracks in the light conductor or in the eye

protector, replace the damaged components.

5353

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Precautions and warnings during the “cleaning and disinfection” of equipment

Unit:

- Before cleaning the equipment, turn off the main switch.

- Avoid spilling water, even accidentally, or other liquids inside the equipment, which could cause short circuits.

- Do not use microabrasive material or steel wool when cleaning, or employ organic solvents or detergents which contain solvents such as ether, stain remover, gasoline etc.

Curring Light:

- The equipment and the light conductor cannot be placed in the oven or autoclaves.

- The conductor can’t be immersed in solvents or substances that contain acetone in its composition.

- Avoid the light conductor to terminal to touch the resin to be polymerized.

- When using the Curring Light check if the light conductor output doesn’t have residues that might obstruct the light beam.

Ultrasound:

- After use, remove the insert to avoid damage.

- The part should be packaged duly clean.

- Do not sterilize the transducer in contact with other types of material.

- The inserts should be cleaned beforehand eliminating all the resin residue.

- After removing the insert from the transducer, it should be disinfected with surgical

spirit and taken to be sterilized in autoclave.

Bicarbonate Jet:

For further information, please see the Jet Hand manual which comes with the product.

Laser Hand:

For further information, please see the Laser Hand manual which comes with the product.

Precautions in case of alteration in the functioning 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 equipment, remove the power supply cable from the socket and contact your representative (Gnatus).

Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation and abandoning of equipment

In order to avoid environmental contamination or undue use of the Equipment after it has become useless, it should be discarded in the suitable place (as per the local legislation of the country).

- Pay attention to the local legislation of the country for the conditions of installation

and disposal of residue.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Additional procedures for reuse

The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing

to be cleaned and disinfected.

Cleaning

Important: In order to execute cleaning or any type of maintenance, ensure that the

equipment is disconnected from the electrical network.

The cleaning procedure below should be executed at the start of the working day and after each patient. Always turn off the main switch before executing the procedures of daily maintenance.

To clean the equipment, we recommend the use of “BactSpray

(Reg nº MS: 3.2079.0041.001-5) or any other similar product:

Active component: Benzalkonium chloride (tri-quaternary

ammonium)

Solution 50%................................................. 0.329%

Chemical composition: Butyl Glycol, Decyl polyglucose, Sodium Benzoate, Sodium Nitrate, Essence, Deodorized Propane / Butane, demineralized Water.

For more information concerning cleaning procedures, see manufacturer’s instructions.

WARNING:

- In order to prevent risks and damages to equipment, make sure

that 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.

NOTE: The registration at the Ministry of Health of the “BactSpray” is executed separately from the product described in this manual, as the “BactSpray” is not manufactured by Gnatus.

Disinfection

Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment. Never use corrosive disinfectants or solvents.

Note: Use gloves and other systems of protection, during the disinfection.

5555

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Cleaning Curring Light

The light conductor cleaning and the optical protector must be done using only neutral

soap and cotton. To the exterior of the pen use neutral soap or alcohol 70% vol.

Never use any other chemical based product than previous mentioned, because along

the time these products attack the surface of the instrument.

Never immerse the instrument in disinfection baths.

Ultrasound

The device is reusable in unspeciﬁ ed quantities, ie endless, only requiring cleaning and

disinfecting.

Cleaning of terminal, transductor cover and hose:

We recommend using a clean cloth, dampened with water and mild soap.

Autoclavable:

Transducer-Cover, inserts and key are autoclavable under the following conditions:

- Maximum temperature of 134 º C.

Transducer cover sterilization:

Remove the insert from the transducer. Carefully remove the cover (01) from the transducer (02) then take it to autoclaving (packed).

Recommendations for autoclave sterilization:

- The piece must be properly packed clean.

- Do not sterilize the transducer cover in contact with other materials.

- The inserts must be cleaned earlier eliminating all resin residues.

- After removing the insert from the transducer, it should be disinfected with surgical alcohol

and taken to autoclave for sterilization.

- The material of the transducer cover was developed to support up to 200 cycles of

autoclaving, provided the recommendations are done according to stated above.

CAUTION: Never expose the transducer covers to any type of oil because it can modify the

structure of the material compromising it´s useful life.

Laser Hand:

For further information, please see the Laser Hand manual which comes with the product.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Bicarbonate Jet "Jet Hand"

For further information, please see the Jet Hand manual which comes with the product.

Reservoirs

It’s highly recommended the cleaning of the water reservoirs, using chlorinated water

solution 1:500 (as described previously).

Bio-System

Remove the terminal hand parts. Take the hand parts

of terminals to the sink or tank of water unit.

Completely open the spray register of the terminals. Press the Bio-System triggering button for some seconds, located under the coupling panel reaching arm of the water unit, to perform the disinfection of internal components with bactericidal liquid. Then, trigger the control pedal for a few seconds to perform rinsing in order to remove chemical residues of bactericidal liquid internally retained in the components of water unit.

Important: This procedure should be done in the beginning of the workday and after each patient.

Triple syringe

Only the syringe tip is autoclavable (01). The other pieces must be cleaned using a piece of cotton wool and alcohol 70% vol. Never use a hot air sterilizer.

Tips support

To remove tips support from equipment, just pull it, as shown in ﬁ gure.

To clean tips support (02) use water and neutral soap. To sterilize in autoclave, use a 134°C cycle. The tips support was designed to stand more than 200 autoclave cycles.

5757

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Preventive Maintenance

The equipment should be calibrated routinely, as per the legislation in force in the country. But never with a period exceeding 3 years. In order to protect your equipment, seek Gnatus technical assistance for periodic revisions

of preventive maintenance.

Corrective Maintenance

If the equipment has any abnormality, check if the problem is related to any of the items

listed in the item Unforeseen Events (situation, cause and solution).

If it is not possible to solve the problem, turn off the equipment, and request Gnatus

technical assistance.

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS

Upon coming across any problem in operation, follow the instructions below to check and repair the problem, and/or get in touch with your representative.

Problem Probable cause Solution

Delivery Unit

-Handpiece is not working. - Compressor disconnected. -Plug the compressor in.

-Handpiece with low speed. -Inlet pressure below speci-

-No water from handpiece spray.

-No water from syringe. -Reservoir run out of water.

-When Bio-system is operated no disinfectant come from handpiece terminals.

ﬁ ed (80 PSI).

- Insufficient air pressure from compressor.

-Reservoir run out of water.

-Closed terminal.

-Compressor disconnected.

-Bio-system reservoir run out of water.

- Chair fuse burned.

-Main or chair switch is off

-Adjust inlet pressure (80 PSI).

Adjust air ﬂ ow.

- Put ﬁ ltered water in reser- voir.

- Open terminal.

-Put ﬁ ltered water in reser- voir.

-Plug compressor in.

-Put disinfectant in the reservoir.

- Turn off the chair from mains power and request a Technician presence.

-Switch main/chair switch on.

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS

Upon coming across any problem in operation, follow the instructions below to check and repair the problem, and/or get in touch with your representative.

Problem Probable cause Solution

- X ray view does not work

-Chair’s fuse burned.

-Main switch is off.

-Turn off the chair from mains power and request a Technician presence.

-Switch the main switch on.

Curring Light

-Equipment’s not working.

-Equipment is not polymerizing resins.

Ultrasound

-The equipment doesn’t work.

-Lack of power to the ultrasound.

-There is no water in the hand piece.

Bicarbonate Jet - For further information, please see the Bicarbonate Jet

Laser Hand - For further information, please see the Laser Hand manual

-Power cut.

-Chair’s fuse burned.

-Resin is not appropriate for LED’s photopolymerizer wave length range.

-Chair’s fuse burned -Turn off the chair from mains

- Deformed insert.

- Loosen insert.

- Bad utilization (incorrect attack angle).

- Inadequate alimentacion pressure water.

- Bad regulating of the water ﬂ ux.

"Jet Hand" manual which comes with the product.

which comes with the product.

-Check power supply.

-Turn off the chair from mains power and request a Technician presence.

-Get the indicated resin for the photopolymerizer’s wave length range, one with contains photoinitiators based on camphorquinone.

power and request a Technician presence.

- Change the insert.

- Hold the insert with the key

- See item “Technical and applications”.

- Correct the water ﬁ lter.

- Adjust the water ﬂ ux throu- gh the actuator.

5959

WARRANTY OF EQUIPMENT

This equipment is covered by the warranty terms counting from the date of installation, as speciﬁ ed below; provided that the defect has occurred in normal conditions of use and that the equipment has not remained stored for more than 06 months counting from the issue date of the sales document until the date of the actual installation.

- WARRANTY TERMS: Verify the guarantee certiﬁ cate;

- LOSS OF THE WARRANTY:

A) Attempt to repair using an inadequate tool or by unauthorized technicians;

B) Installation of the equipment by an unauthorized technician;

C) Damage arising from inappropriate storage or signs of infringement;

D) Incorrect use of the equipment;

E) Use of a cleaning product not indicated by the factory;

F) Falls or blows which the equipment may undergo or lack of observation of an compliance with the guidelines of the Owner’s Manual, which was delivered with the present document, together with the equipment. Repair or replacement of parts during the warranty period shall not extend the validity term of their warranty.

- This warranty doe snot exempt the customer from paying the service charge for the visit and the travel expenses of the technician, except when the customer sends the equipment to execute the maintenance inside the establishment of the technical assistance. “Consumer Defense Code - art. 50, unique paragraph”.

- The Warranty Certiﬁ cate comes with the product and must be ﬁ lled in upon the date of installation by the Gnatus Authorized Technician.

- Queries and information: GNATUS Help Desk (+55) 16 2102-5000 / SAC: 08007015-054.

- Check the warranty term attached to this manual.

FINAL CONSIDERATIONS

The most important aspect related to equipment care is that concerning spare parts. To guarantee the life span of your equipment, use only original Gnatus spare parts. They are sure to follow the technical speciﬁ cations and standards required by Gnatus.

We must also point out to you our chain of authorized dealers. Only dealers that make part of this chain will be able to keep your equipment constantly new for they count on technical assistants who have been trained and on spediﬁ c tools for the correct maintenance of your equipment.

Doubts and information: GNATUS Call center (55-16) 2102-5000 / SAC: 0800-7015-054.

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Gnatus Syncrus G8 H User manual

Specifications and Main Features

Frequently Asked Questions

User Manual