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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Owner’s Manual – New Versa Chair