PRESENTATION OF MANUAL

OWNER’S MANUAL (INSTRUCTIONS FOR USE)

Technical Name: Dental Light
Trade Name: Persus L Dental Light
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 nº: 10229030063

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
- Indication of Equipment .................................................................................04
- Equipment Description....................................................................................04
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION......05
TECHNICAL SPECIFICATIONS........................................................................07
- General.........................................................................................................07
- Standards applied..........................................................................................07
- Dimensions...................................................................................................08
- Packing symbols ............................................................................................12
- Product symbols ............................................................................................12
- Content of accessible and non-accessible demarcations ......................................12
- Electromagnetic emissions...............................................................................13
INSTALLATION OF EQUIPMENT.....................................................................16
OPERATION OF EQUIPMENT..........................................................................16
PRECAUTIONS, RESTRICTIONS AND WARNINGS...........................................18
- Transportation, storage and operation...............................................................18
- Sensitiveness to environmental conditions foreseeable in normal situations of use..18
- Precautions and warnings “during the installation” of equipment...........................18
- Recommendations for preserving the equipment.................................................18
- Precautions and warnings “during the use” of equipment.....................................19
- Precautions and warnings “after” the use of equipment.......................................19
- Precautions and warnings during the “cleaning and disinfection” of equipment........19
- Precautions in case of alteration in the functioning of equipment...........................19
- Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment.......................................20
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............20
- Additional procedures for reuse........................................................................20
- Cleaning.......................................................................................................20
- Disinfection...................................................................................................21
- Replacing the Reflector’s lamp..........................................................................21
- Replacing the fuses........................................................................................22
- Preventive Maintenance..................................................................................22
- Corrective Maintenance...................................................................................22
UNFORESEEN EVENTS – SOLUTION OF PROBLEMS.........................................23
WARRANTY OF EQUIPMENT...........................................................................23
FINAL CONSIDERATIONS...............................................................................23

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IDENTIFICATION OF 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.

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.

Equipment Description
Focal dental reflector with multi intensity light ranging from 8.000 to 25.000 Lux.
Hinged arm with horizontal and vertical movements with a stroke limit jamb, sustained
by a set of springs that allow a smoother and accurate movement.
Handle-shaped bilateral knobs, embedded to the head. With an appropriate design for
placing sterilized protectors avoiding the risk of cross contamination.
Multi-sided glass mirror with multi-coating treatment generates several white and cold
light sources. Do not provoke shadows caused by the surgeon dentist’s hands or head
interposition.
Sturdy and easy to remove hollow optical mirror protector, making the lamp replacement
easier.
Trigging through the chair’s control paddle*, optimizing biosafety or through a switch
shaft* embedded to the reflector’s head (depending on the coupling).
Flat high gloss epoxy painting polymerized in an oven at 250°C; with corrosion and
cleaning material resistant phosphate treatment. Ice colored as standard, compatible with
every environment.

In order to ensure a safety working of you unit, only use the assembly setup (Chair,
Equipment, water unit and reflector) supplied by Gnatus Authorized Resale / Technical
Assistance.
ISO 9001 and ISO 13485 quality systems, assuring that the products are produced
within standard procedures.
Products manufactured in compliance with the resolution RDC 16/13 – Brazil Health
Surveillance Agency - ANVISA.

* Optional item

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION

07

02
05

04 03
09 01 06

The content on this page is informative; the equipment can be different from
those illustrated. Therefore, when purchasing the product check the technical
compatibility between equipment, coupling and accessories.

* 01 - Switch Shaft On/Off

02 - Multi-sided glass mirror
03 - Protective cover
04 - Handles
05 - Bulb protector
06 - Bulb
07 - Hinged arm

* Optional item

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF
CONSUMPTION

01 02 03

*Supports for coupling *Support for coupling *Hinged arm

to the chair floor/ceiling
(Allows the installation of the (Allows the installation of the
hinged arm) hinged arm)

04 05

*Double stand hinged arm *Simple stand

hinged arm
The use of the options must be checked at the time of buying.
Therefore, when buying the product, check the technical
compatibility between the equipment, coupling and
accessories.
06
The use of any part, accessory or material non-specified
or provided Within these use instructions is of the user’s
entire responsibility.

The coupling supports may vary according the purchased *Bush Kit
model of chair. (Allows the fixation of the reflector
in the office with 38mm columns)
*Orbital movement (Allows many angles within the
operatory field illumination).

* Optional item

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TECHNICAL SPECIFICATIONS
General
Classification of Equipment as per ANVISA:
Class I
Classification of Equipment as per standard IEC 60601-1:
Protection against Electric Shock - Type B and Class I Equipment (IEC 60601-1)
Protection against harmful water penetration:
IPX 0
Mode of Operation:
Continuous operation

Installation options:

Chair, stand, floor and ceiling

Tension / frequency:
12V~: Reflector coupled to the dental chair
127/220V~ 50/60Hz: Reflector coupled to the floor, stand and ceiling
Power consumption:
55VA
Luminosity:
8.000 a 25.000 LUX ±20%
Lamp:
H3 12V 55W
Fuses:
5A
Distance between the headstock and the operative field:
70cm
Net weight / Gross:
headstock: 1,0kg / 1,5Kg
Packing dimensions:
23 x 32 x 45 cm

Standards applied:
NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para segurança;
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;
NBR ISO 9680:2001 - Aparelho de iluminação bucal

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TECHNICAL SPECIFICATIONS
Dimensions (mm)
(Standard arm)

8
TECHNICAL SPECIFICATIONS
Dimensions (mm)
(Floor)

9
TECHNICAL SPECIFICATIONS
Dimensions (mm)
(Simple Stand)

10
TECHNICAL SPECIFICATIONS
Dimensions (mm)
(Double Stand)

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TECHNICAL SPECIFICATIONS
Packing symbols
It determines the maximum Packing to be transported and
quantity of boxes which can be / or stored avoiding humidity,
stacked during transportation rains and wet floor.
and storage “as per packaging”.

Packing to be transported and / or The packing must be stored and

stored with the harrows up. transported away from direct
sun light exposure.

Packing to be transported and / or Temperature limit for the

stored with care (should not suffer packing to be stored or
drop and neither receive impact). transported.

Product symbols
Important: It indicates an Grounding (at several points of
instruction of safety for operation the equipment) indicates the
of the product. Not following it, condition of being grounded.
can lead to serious danger to
the patient.
B type applied part
Note: It indicates useful
information for operation of the
product. Warning - see the manual
Important: It indicates an
instruction of safety for operation
of the product. Not following it,
can lead to serious danger to Authorized representative in
the patient. the European Community

Content of accessible and non-accessible demarcations

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TECHNICAL SPECIFICATIONS
Electromagnetic emissions

13
TECHNICAL SPECIFICATIONS
Electromagnetic emissions

14
TECHNICAL SPECIFICATIONS
Electromagnetic emissions

The materials used to produce the equipment are Biocompatible.

Use of different cables, transducers and accessories from those specified

may result in increased emissions or decreased immunity of the equipment.

15
INSTALLATION OF EQUIPMENT
The installation of this equipment requires specialized technical
assistance (Gnatus).

These information also make part of the Manual of Installation and

Maintenance of the equipment that can be found with the authorized
Gnatus technician.

This equipment shall only be able to be unpacked and installed by a Gnatus authorized
technician, under penalty of losing the warranty, as only (s)he has the information, suitable
tools and training required to execute this task.
Gnatus bears no responsibility for damages or accidents caused by poor installation
executed by a technician not authorized by Gnatus.
Only after the equipment has been installed and duly tested by the authorized technician
representing Gnatus, will it be ready to start work operations.

OPERATION OF EQUIPMENT
How to start the reflector
*Features a luminosity control with progressive
adjustment or single intensity (on/off).

Coupled to the floor and stand

Just turn the on/off switch to start the
reflector (01).

01

Coupled to the chair with a “7

function” paddle 02
To start the reflector, push button (02)
through the dental chair’s control paddle
and keep pressing it to change luminosity;
luminosity will gradually change.
To turn it off, Press button (02) once more.

* Optional item

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OPERATION OF EQUIPMENT
Coupled to the chair with an “11
function” paddle
To start the reflector at maximum luminosity,
press button (04). To turn it off, press it again.
To modify luminosity start the reflector
pressing button (03) which will turn it at the
higher defined luminosity, by keeping it pressed,
the luminosity will increase or decrease. To turn
it off, press the button (03) again.

03 04
Coupled to the chair with a “Chip
Blower” paddle
Features a multifunctional key for activating
the reflector.
To start the Reflector at maximum luminosity,
press the button (04). To turn it off, press it again.
To modify the luminosity start the reflector
pressing the button (03) which will turn it at the
higher defined luminosity, by keeping it pressed;
the luminosity will increase or decrease. To turn
it off, press the button (03) again.

WARNING:
For the Equip (without Bien Air panel)
the paddle key (03) will have the function of 03 04
inverting the micro-electric engine rotation.

Movement of the headstock

The movement of the headstock is made
through the knob (06), totally ergonomic
designed to provide absolute isolation.

IMPORTANT:
06 Position the headstock 70cm of the
operative field.

Warning
When handling the equipment, take care with
the parts that could pinch fingers.

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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 floor;
- 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 specified 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 efficacy, 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
fields, 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 equipment

- The equipment should only be installed by Gnatus authorized technical assistance or
technicians.
- 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, or sulfur compounds.
- 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 inflammable with air, or oxygen and nitrous oxide can be detected.
- Check the voltage of the equipment at the moment of executing the electrical installation.
- Before the first 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.

Recommendations for preserving the equipment

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

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PRECAUTIONS, RESTRICTIONS AND WARNINGS
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.
- 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.

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.

Precautions and warnings during the “cleaning and disinfection”

of equipment
- Before cleaning the equipment, turn off the main switch.
- Avoid spilling water or other liquids inside the equipment, which could cause short
circuits.
- Do not use microabrasive material or steel wool when cleaning, or employ organic
solvents or detergents which contain solvents such as ether, stain remover, etc.

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).

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PRECAUTIONS, RESTRICTIONS AND WARNINGS
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.

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 equipment.
• 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.

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CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Cleansing of the protector
IMPORTANT: The cleansing of the light’s protector, should only be done using a water-
dampened flannel or cotton. Do not use chemicals of any sort, for it may stain the protector.

Disinfection
- Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.
- Never use corrosive disinfectants or solvents.

Note: Use gloves and other systems of protection, during the disinfection.

Replacing the Reflector’s lamp

01 A A
05
04
03
02

Turn off the main switch of the chair or turn off the breaker;
Make sure the reflector is cold;
Through the use of a wrench (01) remove the protection (02) smoothly pressing the
fixation lock (A) following the arrow.
Unscrew the deflector (03) and pull the lamp (04) carefully until you locate the terminals
(05);
Disconnect the terminals and replace the lamp.
WARNING:
Never change the lamp bulb with the fingers.
Do it with a paper tissue.

21
CORRECTIVE AND PREVENTIVE MAINTENANCE AND
PRESERVATION
Replacing the fuses
Turn the switch off;
Find the fuse box under the stand (01), next to the transformer (02) and replace the
fuses (03).

Simple Stand Double Stand

01 01
02 02

03

03 03

Preventive Maintenance
The equipment must suffer routinely measurements, following the current legislation
of the country.
But, never with a period superior to 3 years.
For protecting your equipment, look for a Gnatus’ technical assistance for periodic reviews
as preventive maintenances.

Corrective Maintenance
Gnatus states that the supplying of the circuits’ diagram, Part lists or any other information
that permits the technical assistance by the user, can be requested, since previously agreed
between the buyer and Gnatus.

In case of the equipment presents any abnormality; check if the problem is related
to some of the listed items under the item Unpredictable (situation, cause and
solution). If it’s not possible to solve the problem, shutdown the equipment and call
Gnatus’ technical assistance.

22
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
Problem Provável Causa
Probable cause Soluções
Solution

-0The Dental Light does not - Power failure. - Wa i t f o r p o w e r t o

turn on. return.

- Burnt fuse. - Replace the fuse.

- Burnt lamp. - Replace the lamp.

EQUIPMENT’S WARRANTY
This equipment is covered by the warranty terms and norms contained in the Warranty
Certificate that accompany the product.

FINAL CONSIDERATIONS
Among the care you have to take with your equipment, the most important is regarding
of the spare parts replacement.
To ensure the lifetime of your device, only replace original spare parts from Gnatus. They
have the assurance of the standards and technical specifications required by the Gnatus
representative.
We call your attention to our authorized resellers’ chain. Only this chain will keep your
equipment constantly new, because it has trained technical assistant and specific tools for
the correct maintenance of your device.
Whenever you need, demand the presence of a Gnatus’ technician from the nearest
resale, or ask through the Attendance Service GNATUS: + 55 (16) 2102-5000 / SAC: 0800-
7015-054.

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