Gnatus Mini Delivery Unit User manual
PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
EQUIPMENT:
Technical Name: Dental Delivery Units and Accessories
Trade Name: Mini 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.
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INDEX
PRESENTATION OF MANUAL .........................................................................02
IDENTIFICATION OF 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 ................................................................................06
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....07
TECHNICAL SPECIFICATIONS ......................................................................09
- Technical features of the Delivery Unit and its accessories ................................... 09
- Standards applied ........................................................................................11
- Dimension ...................................................................................................12
- Symbologies of packaging .............................................................................13
- Symbologies of product ..................................................................................13
- Contents of the accessible and inaccessible markings .........................................14
INSTALLATION OF EQUIPMENT ...................................................................14
OPERATION OF EQUIPMENT ........................................................................15
- Activation of Terminals ..................................................................................15
- Adjustment of Spray .....................................................................................15
- Activation of ejectors .....................................................................................15
- Use of 3-Way Syringe ...................................................................................16
- Curing Light Activation ...................................................................................16
- Laser Hand Activation ....................................................................................17
- How to supply the reservoirs ..........................................................................18
PRECAUTIONS, RESTRICTIONS AND WARNINGS .........................................19
- Conditions of transport and storage ................................................................19
- Environmental conditions of operation .............................................................19
- Sensitiveness to environmental conditions foreseeable in normal situations of use .19
- Precautions and warnings “during the installation” of equipment .........................19
- Recommendations for preserving the equipment ................................................20
- Precautions and warnings “during the use” of equipment ...................................20
- Precautions and warnings “after” the use of equipment .....................................20
- Precautions and warnings during the “cleaning and disinfection” of equipment ......21
- Precautions in case of alteration in the functioning of equipment .........................21
- recautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment .....................................21
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION ...........21
- Additional procedures for reuse ......................................................................21
- Cleaning .....................................................................................................22
- Preventive maintenance ................................................................................24
- Corrective maintenance..................................................................................24
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS .......................................25
WARRANTY OF EQUIPMENT .........................................................................26
FINAL CONSIDERATIONS .............................................................................26
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.
Identication
Technical Name: Dental Delivery Units and Accessories
Trade Name: Mini Delivery Unit
Brand: GNATUS
4
DESCRIPTION OF THE EQUIPMENT
Principles and bases applied to the functioning of the product
Posee mangueras con aire comprimido y conectores para la alimentación de las piezas
de mano (alta y baja rotación) y jeringa con salida de agua y aire.
It has ejectors, with suction activated by a venturi system or vacuum pump with
compressed air.
Description of Equipment
MINI DELIVERY UNIT is a portable unit with great fastening versatility. (E.g. tables,
cabinets, benches, etc).
Body made of high impact polystyrene.
Activation and control of the syringe, rotary instruments etc., providing greater proximity
in the work field.
Saliva/blood ejector with intermediary filter easy to access.
Automatic selection of the handpieces through sensitive pneumatic valves.
Unique foot control of activation of the handpieces, which can be activated in any
position.
Smooth, rounded hoses, without grooves or riing.
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.
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 9001/2000 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).
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.
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DESCRIPTION OF THE EQUIPMENT
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.
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.
6
MODULES, ACCESSORIES, OPTIONS AND MATE
RIALS OF CONSUMPTION
Delivery Unit Mini
09
10
11
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 - “Venturi or vacuum pump” ejector (optional)
02 - Triple syringe
03 - High-speed-motor terminals (optional)
04 - Low-speed-motor terminal (optional)
05 - Support of the Points (optional Point four)
06 - Bod
07 - Delivery unit cover
08 - Foot control
09 - Kit Laser Hand (optional)
10 - Curing Light (optional)
11 - Bicarbonate jet “Hand”(optional)
12 - Bio-System activation (optional)
“available in the delivery units configured with
Bio-System”
01
01
02
03
04
Basic configuration of the product (composed of)
1-Triple syringe, 1-High-speed-motor terminal TB, 1-Low-speed-motor
terminal (without spray).
12
08
07
06
05
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.
7
MODULES, ACCESSORIES, OPTIONS AND MATE
RIALS OF CONSUMPTION
01
04
01 - Terminals (optional)
- FO:Optical fiber terminal
- TM:Midwest terminal
- TB:Borden terminal
02 - Curing light + tip for 3 teeth
(optional)
03 - Bicarbonate jet kit “Jet
Hand”(optional)
- Bicarbonate jet
- Opener
- Covers for reservoir
- Rings for sealing
02
03
05
- Sachet of bicarbonate
- Manual
04 - Hand Laser kit (optional)
(Nº Registration Anvisa 80051420005)
- Laser Hand
- Safety goggles “patient and
professional”
- Manuals
05 - Ejectors (optional)
- Venturi Ejector
- Larger ejector for Vacuum Pump
- Smaller ejector for Vacuum Pump
- Brush for cleaning the ejector
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.
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TECHNICAL SPECIFICATIONS
Technical features of the Delivery Unit and its accessories
General
Model
Mini 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 inammable with air, oxygen or nitrous
oxide.
Mode of Operation
Continuous operation with intermittent load
Power Supply
Inlet air pressure
80 PSI (5,52 BAR)
Other specications
Capacity of water reservoir
800ml
High rotation air consumption
9 l/min
High rotation water consumption
0,02 l/min
Inlet air pressure - Syringe
40 PSI (2,76 BAR)
Syringe air consumption
17 l/min
Syringe water consumption
0,1 l/min
Net weight (with all the options)
2.55 Kg
Gross weight (with all the options)
3.20 Kg
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