Dabi Atlante New Versa User manual

OWNER'S
MANUAL
New Versa
Chair
English

MANUAL OVERVIEW
EQUIPMENT MANUAL (INSTRUCTIONS FOR USE)
GMDN: 47144 Dental Chair, electric
Technical Name: Dental Chair
Brand: Dabi Atlante
Commercial Name: New Versa Chair
Supplier/ Manufacturer:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brazil
Telephone [phone]
Technical manager: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration No.: 10101130085
WARNING
For greater security:
Read and understand all instructions contained in these
Instructions for Use before installing or operating this Equipment.
Note: These Instructions for Use must be read by all operators of
this Equipment.
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TABLE OF CONTENTS
EQUIPMENT IDENTIFICATION............................................................................... 5
Principles and fundamentals applied to the product operation ........................................ 5
Equipment Purpose .................................................................................................. 5
Equipment Description.............................................................................................. 5
Equipment Indication................................................................................................ 5
MODULES, ACCESSORIES, OPTIONS AND CONSUME MATERIALS.......................... 6
TECHNICAL SPECIFICATIONS ............................................................................... 7
General features ...................................................................................................... 7
Electromagnetic emissions ........................................................................................ 9
Dimensions (mm) .................................................................................................. 13
Packing symbols .................................................................................................... 14
Product Symbols .................................................................................................... 14
EQUIPMENT INSTALLATION ................................................................................ 15
EQUIPMENT OPERATION..................................................................................... 18
Multifunctional Pedal............................................................................................... 20
PRECUTIONS, RESTRICTIONS AND WARNINGS................................................... 21
Transport, storage and operation conditions .............................................................. 21
Sensitivity to predictable environmental conditions in normal use situations .................. 21
Precautions and warnings “during equipment installation” ........................................... 21
Recommendations for equipment maintenance .......................................................... 22
Precautions and warnings “during equipment use” ..................................................... 22
Precautions and warnings “after” equipment use........................................................ 22
Precautions and warnings during equipment “cleaning and disinfection”........................ 23
Precautions in case of change in the equipment operation........................................... 23
Precautions for reducing environmental impact .......................................................... 23
Precautions in case of equipment disuse ................................................................... 24
Precautions to be taken against foreseeable or unusual risks, related to equipment
deactivation and abandonment.............................................................................. 24
CONSERVATION AND CORRECTIVE AND PREVENTIVE MAINTENANCE................. 25
Additional procedures for reuse................................................................................ 25
Cleaning ............................................................................................................... 25
Disinfection ........................................................................................................... 25
Preventive Maintenance .......................................................................................... 26
Corrective Maintenance........................................................................................... 26
UNFORESEEN EVENTS - TROUBLESHOOTING....................................................... 26
EQUIPMENT WARRANTY..................................................................................... 27
FINAL CONSIDERATIONS .................................................................................... 27
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EQUIPMENT IDENTIFICATION
Dear Client
Congratulations on your excellent choice. For buying equipment with “Dabi Atlante”
quality, you can be absolutely sure that you are purchasing products with technology
compatible with the best in class in the world.
This manual gives you an overview of your equipment. It describes important details
that can guide you in its correct use, as well as in solving small problems that may
eventually arise.
We advise you to read it thoroughly and keep it for future reference.
Product Identification
Technical Name: Dental Chair
Commercial Name: New Versa Chair
Brand: Dabi Atlante
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EQUIPMENT IDENTIFICATION
Principles and fundamentals applied to the product operation
Chair for accommodation of the patient during dental treatment, activated by the
control pedal, where commands are sent from the electronic board to two motors
responsible for the movement of the seat mechanism and chair back.
Equipment Purpose
The purpose of this equipment is to accommodate the patient in a comfortable way for
dental practices.
Equipment Description
The product was conceived in order to maximize the professional dental surgeon's and
the patient's experience, by bringing features that bring benefits on a daily basis, such
as:
- Lateral lifting system: greater accessibility and ease of practice.
- Seated patient entry: easier for patients with mobility limitations.
- Trendelenburg position: automatic position with the chair movement.
- Large tray: space to accommodate all instruments.
The equipment was constructed using a range of specific materials for each function,
namely: steel, cast iron and aluminum in its structure; polyurethane, PVC and leather in
its upholstery, steel, plastic and integral-skin in the finishing; plastic or glass in the
reflector.
In addition, copper, acrylic, silicone, silicon, tin, among others is used.
Equipment Indication
This equipment is for dental use only, and must be used and handled by a qualified
person (duly regulated professional, according to the country local legislation) observing
the instructions contained in this manual.
It is the user's obligation to only use the equipment in perfect condition and to protect
him/herself, patients and third parties against possible dangers.
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MODULES, ACCESSORIES, OPTIONS AND CONSUME
MATERIALS
The drawing illustrates the equipment with all optional items, your equipment will consist only of
the items chosen during your purchase option.
01 02 03
05
04 08
06 07
01 - Headrest
02 - Chest backrest
03 - Fixed arms
04 - Seat
05 - Footrest
06 - Joystick
07 - Integral Skin Base
*08 - Multifunctional pedal
* Optional item
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TECHNICAL SPECIFICATIONS
General features
Product Classification:
As per NBR IEC 60601-1
Feeding
127/220 V~ Selectable
Frequency
50/60 Hz
Type of protection against electric shock
Class I Equipment
Degree of protection against electric shock
Type B Applied Part
Mode of operation
Continuous, with intermittent charge - 1min. work and 4 min. rest
Protection against harmful water penetration
IP00 - The entire chair for exams, except the command pedal
IP01 - Command pedal
Input power
530VA
Protection Fuses
F1 and F2 127V - T10A/250V
F1 and F2 220V - T5A/250V
Lifting capacity
200 kg distributed load (patient mass + accessories and equipment)
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TECHNICAL SPECIFICATIONS
The parts of this equipment are not subject to degradation due to wear, corrosion,
fatigue or aging of materials, during its shelf-life.
Emergency stop
The chair has an automatic movement stop button - “Emergency Stop”.
This key, when pressed, automatically blocks all movements and functions of the
chair, and you just have to activate it again for the release and normal operation of the
equipment, maintaining the previously recorded programs and positions.
Overcurrent protection
The equipment is equipped with a safety device for overcurrent, by means of 2 fuses
and internal overcurrent protection for equipment attached to the chair.
Electronic System
The chair has an integrated electronic system with low voltage, which allows total
interface with reflectors, equipment and electronic water units Dabi Atlante, providing
greater safety to the patient and the professional, in addition to greater durability of
the components.
Parts lists and circuit diagrams
Dabi Atlante declares that the provision of Circuit Schemes, Parts List or any other
information that provides technical assistance by the user, may be requested, as long as
previously agreed, between the user and the Company Dabi Atlante.
The materials used in the construction of the equipment are Biocompatible.
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TECHNICAL SPECIFICATIONS
Electromagnetic emissions
Electromagnetic emissions
New Versa Chair is intended for use in the electromagnetic environments specified below. The
customer or the user of the New Versa Chair should assure that it is used in such an environment.
Emission Assay
Compliance
Electromagnetic environment - Guide
RF Emissions
ABNT NBR IEC CISPR 11
Group 1
New Versa Chair uses RF energy only for its
internal function. However, its RF emissions
are very low and are not likely to cause any
Interference with nearby electronic
equipment.
RF Emissions
ABNT NBR IEC CISPR 11
Class B
IEC Hormone Emissions
61000-3-2
Class A
New Versa Chair is convenient for use in all
establishments, including domestic
establishments and those directly connected
to a public low voltage electricity supply
network that powers buildings used for
domestic purposes.
Voltage fluctuations/ Flicker
emissions
IEC 61000-3-3
Complies
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TECHNICAL SPECIFICATIONS
Manufacturer's guidelines and declaration - Electromagnetic immunity
New Versa Chair is intended for use in the electromagnetic environments specified below. The
customer or the user of the New Versa Chair should ensure that it is used in such an environment.
Immunity
Assay
Test Level ABNT NBR
IEC 60601
Compliance Level
Electromagnetic
Environment Guidelines
Electrostatic
Discharge (ESD)
IEC 6100-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wooden,
concrete or ceramic. If the
floor is covered with
synthetic material, the
relative humidity should be
at least 30%.
Fast electrical
transients/ pulse
train ("brust")
IEC 61000-4-4
± 2 kV on power
lines
± 1 kV on the
input/ output lines
± 2 kV on power
lines
± 1 kV on the
input/ output lines
It is recommended that the
quality of the energy supply
be that of a typical hospital
or commercial environment.
Outbreaks
IEC 61000-4-5
± 1 kV line(s) to
line(s) ± 2 kV
line(s) to land
± 1 kV line(s) to
line(s) ± 2 kV
line(s) to land
It is recommended that the
quality of the energy supply
be that of a typical hospital
or commercial environment.
Voltage drops,
short interruptions
and voltage
variations in the
power supply input
lines
IEC 61000-4-11
< 5% Ut
(>95% Ut drop) for
0.5 cycle
40% Ut
(60% Ut drop) for 5
cycles
70% Ut
(30% Ut drop) for 25
cycles
< 5% Ut
(>95% Ut drop) for
5s
< 5% Ut
(>95% Ut drop) for
0.5 cycle
40% Ut
(60% Ut drop) for 5
cycles
70% Ut
(30% Ut drop) for 25
cycles
< 5% Ut
(>95% Ut drop) for
5s
It is recommended that the
quality of the energy supply
be that of a typical hospital
or commercial environment.
If the New Versa Chair user
requires continued operation
during power interruptions, it
is recommended that the
New Versa Chair be powered
by an uninterruptible power
supply or a battery.
Magnetic field
generated by the
electric frequency
(50/60Hz)
IEC 61000-4-8
3 A/m
3 A/m
If image distortion occurs, it
may be necessary to position
the equipment away from
the supply frequency or
install magnetic shielding.
The frequency magnetic field
should be measured at the
Installation site to ensure
that it is low enough.
NOTE Ut is the supply voltage c.a. before applying the test level
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TECHNICAL SPECIFICATIONS
Manufacturer's guidelines and declaration - Electromagnetic immunity
New Versa Chair is intended for use in the electromagnetic environments specified below. The
customer or the user of the New Versa Chair should ensure that it is used in such an environment.
Immunity
Assay
Test Level ABNT NBR
IEC 60601
Compliance
Level
Electromagnetic Environment Guidelines
Rf conducted
IEC 61000-4-6
Rf radiated
IEC 61000-4-
3
3 vrms
150 kHz up to 80 MHz
3 V/m
80MHz up to 2.5 GHz
3 Vrms
3 V/m
It is recommended that portable and
mobile RF communication equipment
should not be used near any part of the
New Versa Chair including cables, with less
than the recommended separation
distance, calculated from the equation
applicable to the transmitter frequency.
Recommended separation distance:
d = 1.2√P
d = 1.2√P 80 MHz to 800MHz
d = 2.3√P 800 MHz to 2.5MHz
Where P is the maximum nominal output
power of the transmitter, and d is the
recommended separation distance in
meters (m). It is recommended that the
field strength from the RF transmitter, as
determined through on-site
electromagnetic inspection, be less than
the level of compliance in each frequency
rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80MHz and 800MHz, the highest frequency range is applied.
NOTE 2 These guidelines may not be applicable in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a - Field strength from fixed transmitters, such as radio base stations for telephones (mobile or cordless phone)
and mobile ground radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be theoretically
predicted precisely. In order to assess the electromagnetic environment generated by fixed RF transmitters, an
electromagnetic field survey should be considered. If the field strength measured at the site where the New Versa
Chair will be used exceeds the applicable RF compliance level defined above, the New Versa Chair should be
observed to verify that it is functioning normally. If abnormal performance is detected, additional measures may be
necessary, such as reorienting or relocating the New Versa Chair.
b - Above the frequency range of 150kHz to 80 MHz, it is recommended that the field strength is less than 3 V/m.
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TECHNICAL SPECIFICATIONS
Recommended separation distances between mobile, portable RF communication equipment and the
New Versa Chair
The New Versa Chair is intended for use in an electromagnetic environment in which RF
disturbances are controlled. The customer or user of the New Versa Chair can help prevent
electromagnetic interference by maintaining a minimum distance between mobile and portable RF
communication equipment (transmitters) and the New Versa Chair as recommended below,
according to the maximum output power of the communication equipment.
Maximum output
power w
Separation distance according to the transmitter frequency
150 kHz up to 80 MHz
d= 1.2√p
80 kHz up to 800 MHz
d= 1.2√p
800 kHz up to 2.5 GHz
d= 2.3√p
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters with a maximum nominal output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the
transmitter frequency, where P is the maximum nominal output power of the transmitter in watts
(W), according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the highest frequency range is applied.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the absorption and reflection of structures, objects and people.
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TECHNICAL SPECIFICATIONS
Dimensions (mm)
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TECHNICAL SPECIFICATIONS
Packing symbols
Maximum stacking, it
determines the maximum
amount of cartons that can be
stacked during transportation
and storage “according to
packaging”.
It determines that the packaging
must be stored or transported
with the arrow side up.
It determines that the packaging
must be stored and transported
with caution (it must not fall or
be impacted).
Product Symbols
Caution: It indicates important
instruction for product operation.
Failure to follow it can cause
dangerous malfunction
Note: It indicates useful
information for product
operation
Important: It indicates safety
instructions for product
operation. Failure to follow it can
result in serious danger to the
patient
Grounding (at various points on
the equipment) indicates the
condition of being grounded
Spitting Position Activation
/ Return to last position
It determines that the
packaging must be stored or
transported protected from
humidity (do not expose it to
rain, water splashes or floors.
It determines that the
packaging must be stored or
transported protected from
light.
It determines the temperature
limits within which the
packaging must be stored or
transported.
On position
Off position
Type B
Seat up
Seat down
Backrest up
Backrest down
It determines the working
positions ”1 and 2”
It determines the working
positions ”3 and 4”
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TECHNICAL SPECIFICATIONS
Product Symbols
Determines the position back to zero Reflector activation:
Authorized representative
in the European community
Reversing the rotation direction
of the electric micro motor
Warning –refer to manual ! Emergency stop
EQUIPMENT INSTALLATION
The installation of this equipment requires the need for specialized
technical assistance (Dabi Atlante).
This information is also part of the equipment Installation and
Maintenance Manual that is in the possession of the authorized
technical representative Dabi Atlante.
For your safety, the Chair leaves the factory positioned at 220V~, so
make sure that your network is compatible before connecting it, if it is
127V~ request the presence of an authorized Dabi Atlante technician.
-This equipment can only be unpacked and installed by an authorized Dabi Atlante
technician, under penalty of loss of warranty, since only he/ she has the information, the
appropriate tools and the training necessary to perform this task.
-Dabi Atlante is not responsible for damage or accidents caused by poor installation
carried out by an unauthorized Dabi Atlante technician.
-Only after the equipment has been installed and properly tested by the authorized
representative Dabi Atlante technician, will it be ready to start work operations.
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EQUIPMENT INSTALLATION
IMPORTANT:
Dabi Atlante dental office is dimensioned so that the stability of the set consisting of
dental chair, equipment, reflector and water unit remains stable under normal use
conditions. If, at the client's discretion, there is a need to install other accessories to the
office, Dabi Atlante informs that it is the client's responsibility to assess the stability, and
suggests that in this case, the base of the chair is fixed to the floor through the holes
already arranged at its base. This makes the added weight not to compromise the set
stability.
How to fix the chair base to the floor
The base of the chair must be fixed to the floor using S-10 Plastic Bushing, Hexagonal
Wood Steel Screw 5/16 ”x 2” ¼, New Versa Office Fixation Plate, indicated for this
purpose, provided by Alliage.
Failure to attach the base of the chair to the floor can cause instability and in extreme
cases the chair fall. There is no safe level of use of the chair unless its base is attached to
the floor.
In the event of a fall or instability of the chair not affixed to the floor that damages it
or causes damage to operators or patients, the responsibility will be the sole
responsibility of the owner.
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EQUIPMENT OPERATION
Main switch
Turn on the main switch located on the back of the product.
Turn off the office after use or at the end of the day.
The main switch has an internal LED that stays on/ off when the
office is on/ off.
If the Chair is in any movement (seat and/or back, working
position) and at this moment there is a power outage or accidental
disconnection of the main switch, when the power supply returns or
main switch is turned on, the key back-to-zero must be activated and
wait for the Chair to complete this movement, for its proper operation.
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Main switch

EQUIPMENT OPERATION
Seat Movement
Activate the joystick vertically up/ down to lower/ raise the seat. To stop the movement,
just stop activating the joystick.
Backrest Movement
Activate the joystick laterally to the left/ right to raise/ lower the backrest. To stop the
movement, just stop activating the joystick.
Longitudinal movement of the headrest - Optional
Rotate the handle located on the back of the Chair back counterclockwise to unlock the
backrest, place it in the desired location and rotate the handle clockwise to fix it.
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EQUIPMENT OPERATION
Positioning the bi-articulated headrest
Rotate the handle counterclockwise to release the mechanism. Position the backrest in
the desired location and turn the handle clockwise to lock the mechanism. Make sure that
the assembly has been sufficiently tightened to prevent movement during use.
Multiarticulated Headrest
Press and hold the pneumatic lock to release the set brake. Position the backrest in the
desired position, when reaching the desired position, release the lock to lock the set.
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Handle
Pneumatic
lock

EQUIPMENT OPERATION
Multifunctional Pedal
The Multifunctional Pedal can be used in two situations, when the hand piece is out of the
holder, the pedal assumes the same functions as the electric Micro Motor pedal, and
when the hand piece is in the tip holder, the pedal resumes its function as the Chair
pedal.
1 - Chip Blower
2 –Back to Zero
3 - Micro Motor Memory
4 - Reflector
5 - Dry tip actuation (pushing the pedal sliding lever to the left)
6 - Counterclockwise (implant removal) by pushing the pedal sliding lever to the left
7 –Working position
8 - Peristaltic Pump
9 - Spitting Position
10 - Spray tip actuation (by pushing the pedal sliding lever to the right)
11 - Clockwise (implant insertion) by pushing the pedal sliding lever to the right
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Owner’s Manual – New Versa Chair