Gnatus Syncrus LS User manual

PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
EQUIPMENT:
Technical Name: Dental Delivery Units and Accessories Trade Name: Syncrus LS Delivery Unit Brand: GNATUS
Manufacturer/ Distribuitor:
GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA. Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500 Ribeirão Preto - S.P. - Brasil Fone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001 C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115 www.gnatus.com.br - gnatus@gnatus.com.br Technical Duties: Gilberto Henrique Canesin Nomelini CREA-SP: 0600891412
Registration ANVISA #: 10229030047
ATTENTION
For greater safety:
Read and understand all the instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all the operators
of this Equipment.
2
INDEX
PRESENTATION OF MANUAL ........................................................................02
DESCRIPTION OF THE EQUIPMENT ...............................................................04
- Dear Customer .............................................................................................04
- Identification ................................................................................................04
- Principles and bases applied to the functioning of the product .............................05
- Description of Equipment ..............................................................................05
- Indication of Equipment ................................................................................07
MODULES, ACCESSORIES, OPTIONS AND TYPES OF COUPLING .....................08
TECHNICAL SPECIFICATIONS .......................................................................12
- Technical features of the Delivery Unit and its accessories ................................... 12
- Eletromagnetic emissions ...............................................................................15
- Standards applied .........................................................................................18
- Dimension ....................................................................................................19
- Packing symbols ............................................................................................20
- Product symbols ............................................................................................20
- Content of accessible and non-accessible demarcations ......................................22
INSTALLATION OF EQUIPMENT ...................................................................22
OPERATION OF EQUIPMENT .........................................................................23
- Turning on / off the dental set ......................................................................... 23
- Positioning ...................................................................................................23
- Activation of Terminals ...................................................................................23
- Adjustment of Spray ......................................................................................23
- Driving to the water in the basin to the model without the control panel ...............24
- Use of 3-Way Syringe ...................................................................................24
- Curing Light Activation ...................................................................................24
- Laser Hand Activation ....................................................................................25
- Ultrasound Activation ...................................................................................26
- “Ultrasound” techniques and applications ..........................................................27
- Activation of Bicarbonate jet ...........................................................................29
- Equipment activation by the delivery unit panel ................................................30
- How to supply the reservoirs ...........................................................................31
PRECAUTIONS, RESTRICTIONS AND WARNINGS .........................................32
- Transportation, storage and operation ..............................................................33
- Sensitivity to environmental conditions in normal situationsof use ........................33
- Precautions and warnings “during the installation” of equipment ..........................33
- Precautions and warnings “during the use” of equipment ....................................34
- Precautions and warnings “after” the use of equipment ......................................34
- Precautions and warnings during the “cleaning and disinfection” of equipment .......34
- Precautions in case of alteration in the functioning of equipment ..........................35
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment .....................................35
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............36
- Additional procedures for reuse .......................................................................36
- Cleaning ......................................................................................................36
- Preventive maintenance .................................................................................39
- Corrective maintenance..................................................................................39
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................40
WARRANTY OF EQUIPMENT ..........................................................................41
FINAL CONSIDERATIONS ..............................................................................42
3
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 LS Delivery Unit
Brand: GNATUS
4
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
Delivery unit for dental use, for the activation and control of the syringe, rotary
instruments, etc., providing greater proximity in the work field.
It has a side panel and central control panel (optional).
Structure made of steel with surface treatment via nanotechnology. Smooth painting with a high gloss and epoxy base, polymerized in an oven at 250ºC, resistant to corrosion and cleaning materials.
Auxiliary tray made of steel with horizontal movement.
Delivery unit body made of high impact polyethylene.
Smooth hoses, without grooves or riing, rounded, light and exible.
It has translucent reservoirs easy to access with automatic pressurization of water for syringe/spray of the handpieces and chlorinated water for the “optional” Bio-System. The Bio-System is a disinfection system, which provides internal cleaning of the hoses and terminals via bactericidal liquid, preventing risks of cross contamination.
Connecting box, made of high impact polyethylene and having rounded corners.
Interchangeable coupling system, adaptable as per the requirement of the professional. Available in the pneumatic FLEX, mechanical FLEX and CART models (optional).
PNEUMATIC FLEX: coupled to the dental chair, with horizontal movements, swivel arm with horizontal and vertical movements, with a pneumatic locking device for the vertical movements, activated by a button located in the body of the delivery unit, and smooth
movements due to the bushing system of Teon with bronze.
MECHANICAL FLEX: coupled to the dental chair, with horizontal movements and adjustment of the vertical position through the snap ring.
CART: with the base on four casters, made of steel with smooth painting and rounded corners.
To guarantee the safe functioning of your equipment, use only the assemble configurations
(Dental Chair, Dental and Water Units and Dental Light) supplied by Gnatus authorized Dealers / Technical Assistance.
EN ISO 9001/2008 and EN ISO 13485/2003 Quality System, assuryng the products are manufactured under standart procedures.
Products manufactured in agreement with RDC 59/2000 - ANVISA - (Sanitary Surveillance National Agency).
5
DESCRIPTION OF THE EQUIPMENT
Laser Hand Kit (optional item) – Features of the product:
See the Owner’s Manual - Laser Hand
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 efficiency, 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.
- 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 specified
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 filter.
• 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.
6
DESCRIPTION OF THE EQUIPMENT
Ultrasound (optional item) – Features of the product:
Piezoelectric Ultrasound, frequency of 30,000 Hz.
The Transducer with the piezoelectric system allows the insert to make precise and linear movements, being able to be used in widely differing dental specialties.
Fine adjustment of power, suited to each type of procedure.
In the procedures with cooling, it offers constant irrigation with control of ow.
It also allows dry work to be executed (condensation of amalgam, cementing of inlays/ onlays etc).
FUNCTIONAL APPLICATIONS
• Periodontics
• Endodontics
• Dentistics and Prosthesis
Bicarbonate jet (optional item) – Features of the product:
The bicarbonate jet removes dark stains from teeth, caused by cigarette smoke, coffee, tea, etc, associated with bacterial plaque and not tartar.
Irrigation with a pneumatic system.
Autoclavable bicarbonate jet handpiece.
Internal pressurization through the terminal of the micro motor of the delivery unit, facilitating its functioning.
It dispenses with external air and water connections.
Internal depressurization through automatic bicarbonate sweeping.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certified 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.
7
MODULES, ACCESSORIES, OPTIONS AND TYPES OF COUPLING SUPPORTS
Syncrus LS Delivery Unit (with panel)
14
10
15
16
17
03
The Drawing illustrates the equipment with all the optional items. Your delivery unit will only be composed of the items chosen during your purchase option.
01 - Control panel 02 - X ray view (optional) 03 - Triple syringe 04 - High-speed-motor terminals (optional) 05 - Centered handle 06 - Low-speed-motor terminal (optional) 07 - Bicarbonate jet (optional) 08 - Bicarbonate reservoir (optional) “available in the delivery units
configured with bicarbonate jet”
09 - Connection box 10 - Foot control 11 - Arm brake valve (optional) “used in the pneumatic Flex couplings” 12 - Water valve for Syringe /FO/MME/ Scaler/bicarbonate jet (optional) 13 - Auxiliary trays 14 - Kit Laser Hand (optional) 15 - Curing Light (optional)
01
02
04
05
06
07
Basic configuration of the product (composed of)
G Coupling: Mechanical Flex, 1-3-Way Syringe, 2- TB/TM/FO high rotation terminals, 1-Terminal for TB/TM micro motor.
11
12
13
09
08
E
D
C
B
A
16 - Ultrasound (optional) 17 - Bicarbonate jet “Hand”(optional)
Side command (see page 11)
A - Main switch of delivery unit B - Regulator of ultrasonic power C - Regulator of MME rotation D - Inversion of MME rotation E - Manometer
Couplings (options upon inquiry)
F - Pneumatic Flex G - Mechanical Flex H - Cart
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.
F
G
H
8
MODULES, ACCESSORIES, OPTIONS AND TYPES OF COUPLING SUPPORTS
Syncrus LS Delivery Unit (without panel)
13
14
15
01
16
18
01 - X ray view (optional) 02 - Triple syringe 03 - High-speed-motor terminals (optional) 04 - Centered handle 05 - Low-speed-motor terminal (optional) 06 - Bicarbonate jet (optional) 07 - Bicarbonate reservoir (optional) “available in the delivery units
configured with bicarbonate jet”
08 - Connection box 09 - Foot control 10 - Arm brake valve (optional) “used in the pneumatic Flex couplings” 11 - Water valve for Syringe /FO/MME/ Scaler/bicarbonate jet (optional) 12 - Auxiliary trays 13 - Kit Laser Hand (optional) 14 - Curing Light (optional) 15 - Ultrasound (optional)
02
03
04
05
06
Basic configuration of the product (composed of)
G Coupling: Mechanical Flex, 1-3-Way Syringe, 2- TB/TM/FO high rotation terminals, 1-Terminal for TB/TM micro motor.
09
19
10
11
12
16 - Bicarbonate jet “Hand”(optional) 17 - Drive button of the water in the basin (optional) 18 - Control Panel Kit (optional) 19 - Bio-System operation (optional)
Side command (see page 11)
A - Main switch of delivery unit B - Regulator of ultrasonic power C - X-ray viewer activation (optional)
Couplings (options upon inquiry)
F - Pneumatic Flex G - Mechanical Flex H - Cart
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. The Drawing illustrates the equipment with all the optional items. Your delivery unit will only be composed of the items chosen during your purchase option.
A
08
17
F
G
07
D
H
C
B
9
MODULES, ACCESSORIES, OPTIONS AND TYPES OF COUPLING SUPPORTS
01
04
07
02
05
08
03
06
09
10
10
11
12
13
MODULES, ACCESSORIES, OPTIONS AND TYPES OF COUPLING SUPPORTS
01 - Terminals (optional)
- MME:Electrical micro motor terminal
- FO:Optical fiber terminal
- TM:Midwest terminal
- TB:Borden terminal
02.a - Side command (with panel)
- Main switch of delivery unit (optional)
- Regulator of ultrasonic power “available in the delivery units
configured with scaler”
- Regulator of MME rotation (optional) “available in the delivery units
configured with MME”
- Inversion of MME rotation (optional) “available in the delivery units
configured with MME”
- Manometer (optional)
02.b - Side command (without panel)
- Main switch of delivery unit
(optional)
- Regulator of ultrasonic
power “available in the delivery units
configured with scaler”
- Manometer (optional)
- Activation of X-ray viewer (optional) “available in the delivery units
configured with X-ray viewer”
03.a - Control panel (optional)
05 - Curing light + tip for 3 teeth
(optional)
06 - Control Panel Kit (optional)
- Up/down backrest keys
- Up/down seat keys
- Reector activation key
- Working positions 1, 2 and 3 keys
- Key Return to zero
07 - Ultrasound kit (optional)
- Ultrasound
- Tightening wrench
- Inserts “nº 1, 2 and 10P
08 - Bicarbonate jet kit (optional)
- Bicarbonate jet
- Opener
- Hose
- Sachet of bicarbonate 09 - Bicarbonate jet kit “Jet
Hand”(optional)
- Bicarbonate jet
- Opener
- Covers for reservoir
- Rings for sealing
- Sachet of bicarbonate
- Manual
10 - X-ray viewer (optional)
03.b - Drive button of the water in
the basin (optional)
04 - Hand Laser kit (optional)
(Registration # Anvisa 80051420005)
- Laser Hand
- Safety goggles “patient and
professional”
- Manuals
The use of any part, accessory or material not specified or foreseen
in these instructions for use is entirely the user’s responsibility.
The accessories described above shall never be able to be sold separately from the product.
11 - CART coupling (optional)
12 - Pneumatic FLEX coupling (optional)
13 - Mechanical FLEX coupling (optional)
11
TECHNICAL SPECIFICATIONS
Technical features of the Delivery Unit and its accessories
General
Model Syncrus LS 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 inammable 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 # phases Single Phase / Biphasic 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
12
TECHNICAL SPECIFICATIONS
Capacity of water reservoir 800ml High rotation air consumption 9 l/min High rotation water consumption 0,02 l/min Syringe air consumption 17 l/min Syringe water consumption 0,1 l/min Delivery unit tray`s maximum load capacity 2Kgf Net weight of Delivery Unit with “Pneumatic FLEX” coupling (with all the options) 22,5 Kg Gross weight of Delivery Unit with “Pneumatic FLEX” coupling (with all the options) 27,5 Kg Net weight of Delivery Unit with “Mechanical FLEX” coupling (with all the options) 17 Kg Gross weight of Delivery Unit with “Mechanical FLEX” coupling (with all the options) 22 Kg Net weight of Delivery Unit with “CART” coupling (with all the options) 15,10 Kg Gross weight of Delivery Unit with “CART” coupling (with all the options) 18,80 Kg
Specications of Curring Light
Power 5,2VA Light source 1 LED Active medium Semicondutor LED (InGaN) Wavelength 440nm - 460nm
13
TECHNICAL SPECIFICATIONS
Timer 90 seconds Timer alarm sound alarm with beep every 10 seconds and 4 beeps at the end of the cycle Activation Through the hand-piece button Light conductor Made out of special polymer, rotational, removable and reuse sable. Hand-piece body ABS injected
Specications of Ultrasound
Frequency of Vibrations of Ultrasound 30,000Hz Consumption of irrigating liquid 28 ml/min Power consumed 15VA ±10% Transducer system Piezoelectric ceramic
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