PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
Technical Name: Dental Chair
Brand: Gnatus
Trade Name: Syncrus POP Dental Chair
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 nº: 10229030041
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
IDENTIFICATION OF EQUIPMENT .................................................................04
- Purpose of equipment ....................................................................................04
- Description of Equipment ...............................................................................05
- Indication of Equipment ................................................................................05
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION .....06
TECHNICAL SPECIFICATIONS .......................................................................07
- Standards applied .........................................................................................08
- List of pieces and circuit scheme .....................................................................08
- Electromagnetic emissions ..............................................................................09
- Contents of the accessible and inaccessible markings ........................................12
- Dimensional .................................................................................................13
- Symbologies of packaging .............................................................................14
- Symbologies of product .................................................................................14
INSTALLATION OF EQUIPMENT ....................................................................15
OPERATION OF EQUIPMENT .........................................................................17
PRECAUTIONS, RESTRICTIONS AND WARNINGS ..........................................19
- Conditions of transport, storage and 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
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment ......................................21
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............22
- Additional procedures for reuse .......................................................................22
- Cleaning ......................................................................................................22
- Disinfection ..................................................................................................22
- Preventive maintenance .................................................................................23
- Corrective maintenance..................................................................................23
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................23
WARRANTY OF EQUIPMENT ..........................................................................24
FINAL CONSIDERATIONS ..............................................................................24
33
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 Chair
Trade Name: Syncrus POP Dental Chair
Brand: GNATUS
Purpose of the equipment
Chair for patient accommodation during dental treatment.
4
DESCRIPTION OF THE EQUIPMENT
Description of Equipment
Dental chair for patients during dental treatment, ambidextrous (for right-handers
and left-handers) with automatic movements, activated by a motor reducer using direct
current. Activation by means of multifunctional foot control, which activates the dental
light, moves the backrest and seat and returns to zero. Power input cable (optional item).
Bold design, with rounded lines, looking modern and harmonious. Spacious, curved
backrest, which as well as providing comfort to the patient, allows easier access for the
dental surgeon.
Base made of steel, with 4 holes for fastening to the oor.
Structure of the unit made of dense steel, with surface treatment using nanotechnology,
coated with smooth, highly shiny resistant material, with rounded edges.
Highly shiny smooth paint with an epoxy base, polymerized in an oven at 250ºC, resistant
to corrosion and cleaning materials.
Anatomic headrest, with height adjustment. Optional neck rest, providing the patient
with greater comfort.
Support of the xed arm with a rounded nishing, planned to facilitate access to the
patient and increase the professional’s productivity, dispense with movement, and facilitate
cleaning and disinfection (optional right arm).
Large upholstery, with lumbar support, assembled on a rigid structure covered with highly
resistant injected polyurethane, covered with laminated, seamless material.
ISO 9001/2000 and ISO 13485/2003 Quality System, assuryng the products are
manufactured under standart procedures.
Products manufactured in agreement with RDC-59 - ANVISA (Sanitary Surveillance
National Agency) with guarantees accomplishiment to the sanitary legislation according to
BPF (Good Manufacturing Procedures). In order to comply with directive 93/42/EEC for CE
Mark purpose, it is dened that the life span of this product is estimated in 05 years provided
that the enduser follows the requirements and instructions of this manual.
IMPORTANT:
• This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certied 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.
• This equipment can’t be used in the presence of inammable anesthetics or products
that may cause explosion.
• After nish life-cycle of the equipment, this equipment is throw way, so it should to be
destroye in appropriate area (according to the legislation of the country).
• To guarantee the safe functioning of your equipment, use only the assemble
congurations (Dental Chair, Dental and Water Units and Dental Light) supplied by Gnatus
authorized Dealers / Technical Assistance.
Indication of Equipment
This equipment is for dental use use only. It must be operated and utilized by specialized
professional (certied 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.
55
MODULES, ACCESSORIES, OPTIONS AND MATERIALS
OF CONSUMPTION
09
02
03
04
05
01
17
08
06
07
10
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.
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.
WARNING: For the chair with integrated connection box is recommended to x the base of
the chair to the oor, as oriented under the item "Installation" of this guide.
01 - Headrest
02 - Chest rest
03 - Foot control
04 - Base
05 - Finishing cover of the motor
06 - On/Off switch
07 - Seat
08 - Fixed left armo
09 - Neck rest *
10 - Fixed right arm *
17 - Headreast double swivel *
* Optional
6
TECHNICAL SPECIFICATIONS
General
Classification of Equipment:
According to norm NBR IEC 60601-1
Supply voltage
127/220 V~ Selecionable
Frequency
50/60 Hz
Electric shock protection type
Class one equipment
Degree of protection against electric shock
B type
Mode of Operation
Continuous with intermittent load: T-on 1min. - T-off 4min.
Water leak protection
IPX0 – All the chair, excepting foot control
IPX1 – foot control
Power
200VA
Protection fuses
F1 and F2.... 5A - Time-lag
Rising capacity
200 Kg
Delivery unit tray’s maximum load capacity
Syncrus line HS - 1 Kg
Syncrus lines LS and S - 2 Kg
Net Weight
104 Kg
Gross Weight
137,3 Kg
77
TECHNICAL SPECIFICATIONS
Chair for left and right-handed dentists use
Chair was designed for easy installation for left and right handed users, without losing
its features.
When the Gnatus authorized technician installs the equipment, tell him whether position
you want, and he will make the necessary adjustments.
Current surge protection
Equipment is protected from current surge by 2 fuses of 5 amperes each and it also
features internal current surge protection for equipment attached to chair.
Standards applied:
NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para segurança;
NBR ISO 6875:1998 - Equipamento odontológico – Cadeira odontológica de paciente;
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.
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.
The materials used to produce the equipment are Biocompatible.
8
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
Use of different cables, transducers and accessories from those specied may result
in increased emissions or decreased immunity of the equipment.
99
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
10
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
1111
TECHNICAL SPECIFICATIONS
Electromagnetic emissions
Content of accessible and non-accessible demarcations
12
TECHNICAL SPECIFICATIONS
Dimensions (mm)
1313
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: I t indi cates an important
instruction for the operation of the
product. Not following it can cause
dangerous malfunctioning.
Note: I t indi cates useful
information for operation of the
product.
Packing to be transported and
/ or stored avoiding humidity,
rains and wet oor.
The packing must be stored and
transported away from direct
sun light exposure.
Temperature limit for
thepacking 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.
Grounding (at several points of the
equipment) indicates the condition
of being grounded.
It determines to spitting position
/ last position.
Lift seat.
Lower seat.
Lift backrest.
Lower backrest.
14
TECHNICAL SPECIFICATIONS
Product symbols
It determines the initial position.
Authorized representative in
the European Community
Activation of the dental light
Warning - Consult the manual
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.
For your safety, the Dental Chair leaves the factory positioned at 220V~,
so ensure that your network is compatible before turning it on. If it is
127V~, request the presence of an authorized GNATUS technician.
- The equipment should only be installed by Gnatus authorized technical assistance or
technicians.
- The bad use, negligence or maintenance not made by technician authorized by the maker,
will imply in the loss of the warranty.
1515
INSTALLATION OF EQUIPMENT
IMPORTANT:
The Gnatus dental set is dimensioned so that the stability of the set composed of a Dental
Chair, Delivery Unit, Dental Light and Water Unit remains stable in normal conditions of use.
If, by option of the customer, it is necessary to install other accessories in the dental set,
Gnatus informs you that the evaluation of the stability is the customer’s responsibility, and
suggests that in this case the base of the dental chair is fastened to the oor by means of
the holes already furnished in its base. This means that the added weight does not jeopardize
the stability of the set.
How to x the dental chair base to the oor
This dental chair must be xed to the oor thru 04 screws and bushing that its along
with the product.
In order to x, rst mark the oor and after drill ø 10mm, adjust the 4 bushings S10
in the hole, and place the chair on the top of the holes and x it with the 04 screws.
Armrest attachment
This Syncrus dental chair is shipped from factory with a xed armrest.
For right-handed users, install the armrest in the chair’s left side; for left-handed users,
install the armrest in the right side of the chair, as shown in the picture below.
Optional second armrest is available for sale.
Attachment of the armrest
to left side for right-handed
users.
Attachment of
the armrest to
right side for left-
handed users.
16
OPERATION
Foot control operation
11 - Working position 1, 2, and 3.
12 - Initial position.
13 - Lift backrest.
14 - Lower backrest.
15 - Lift seat.
16 - Lower seat.
17 - Activation of Dental Light
11
12
17
16
15
13 14
Reector Activation
To turn the reector on press the button (17), to modify the light, hold it, the brightness
will ncrease or decrease gradually, according to the specications of the reector (See the
owner’s reector manual). To turn it off, press the button (17) again.
Working positions
The Syncrus chair has three programmable working positions. To schedule them just put
the eat in position and the reector in the desired intensity and keep the pedal button (11)
pressed, the chair will beep then two consecutive beeps and then three consecutive beeps
entering in a cycle, release the button after the number of consecutive beeps regarding the
working position you want to program.
To select the rst working position touch the pedal button (11), for the second position
touch twice and for the third position touch three times.
• 1 beep = 1st working position
• 2 beeps = 2nd working position
• 3 beeps = 3rd working position
ATTENTION:
After pressing the “initial position” (12), any other operation will trigger the “Stop”.
Headrest
To adjust height just move it vertically.
1717
OPERATION
Replacing the fuse
A – Turn off the main switch of the dental chair and remove the protective cover
loosening the straps.
B – Locate the 2 fuse holders. C - Turn the fuse holder in a
NOTE:
It is advisable to always have a reserve fuse at hand (5A).
18
counterclockwise direction, remove
the fuse and replace it.
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 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 specied in the packaging;
- Transportation and storage temperature range: -12°C to 50°C.
- Ambient temperature range recommended by Gnatus +10 ° C to +35 ° C.
ATTENTION: The equipment should only be used with power input cable supplied by
Gnatus. Otherwise, it may cause an increase in the emissions of reduction in the immunity
of the equipment.
The Equipment maintains its condition of safety and efcacy, 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
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.
- Check that the socket in which the device will be connected has a ground connection.
According to the ABNT standard, this is essential for the safe operation of the system;
- 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.
- 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 in ammable with air, or oxygen and nitrous oxide can be detected.
- Check the voltage of the equipment at the moment of executing the electrical installation.
- The equipment must be grounded correctly.
- Before the rst use and/or after long interruptions from work such as vacations, clean
and disinfect the equipment.
These information also make part of the Manual of Installation and
Maintenance of the equipment that can be found with the authorized
Gnatus technician.
1919
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.
- When moving the chair, never get it for the part of the support of the legs, lift it for
the structure in the area of the seat.
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.
20
PRECAUTIONS, RESTRICTIONS AND WARNINGS
Precautions and warnings during the “cleaning and disinfection”
of equipment
- 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.
Care for the cleaning of (laminated PVC "courvin" or leather) Upholstery:
- Never use any type of alcohol, microabrasive material, detergents containing solvents
such as ether or stain remover for cleaning of upholstery, because it may cause stains.
Procedure for cleaning of laminated PVC (courvin) upholstery:
- We recommend using the product BactSpray (manufactured by AEROPAC INDUSTRIAL
LTDA and distributed by DCMA produtos médicos odontológicos LTDA) or a damp cloth with
a mild soap.
Procedure for cleaning of leather upholstery:
- For cleansing and moisturizing of the leather upholstery, we recommend the use of
exclusive products for this purpose.
- Never soak or scrub forcefully the leather. If dirt falls on the leather staining it, clean
it immediately with a damp cloth with a mild soap.
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.
2121
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.
(EXCEPT FOR UPHOLSTERY)
- Never use corrosive disinfectants or solvents.
Note: Use gloves and other systems of protection, during the
disinfection.
22
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.
Imprevistos Provável Causa Soluções
Problem Probable Cause Solution
- Chair is not working. - Plug disconnected from
socket.
- Connect plug to socket.
- Power cut.
- Main switch is off.
- Burned fuse(s).
- Wait until power is back.
- Switch the main switch on.
- Replace fuse(s)
2323
WARRANTY OF EQUIPMENT
This equipment is covered by the warranty terms counting from the date of installation,
as speci 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 certicate;
- 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 Certi cate comes with the product and must be lled in upon the date
of installation by the Gnatus Authorized Technician.
- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.
- 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 specications 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 spedic tools for the correct maintenance of your
equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
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