SAEVO Dental Light User manual

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MANUAL PRESENTATION
Technical Name: Dental Lights
Commercial Name: Dental Light
Models:
Persus Led
Persus Piso
Brand: Saevo
Technical Responsible: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Registration No.: 10069210069
Document originally written in Portuguese.
Alliage S/A Industrias Médico Odontológico
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500
Ribeirão Preto - SP - Brazil
Phone: [phone]
CINTERQUAL – Soluções de Comércio
Internacional, Lda.
Rua Fran Pacheco No.220 2nd oor
2900-374 Setúbal
Portugal
77000000693 - Rev.: 03 - November/20

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TRADEMARKS
All terms mentioned in this manual that are known trademarks, registered trademarks or service
marks have been appropriately labeled as such. Further products, services or terms that are
mentioned in this manual may be registered marks, registered trademarks or service marks of their
respective owners. Alliage S/A makes no claims regarding these trademarks. The use of a term in
this manual should not be considered to inuence the validity of any registered mark, registered
trademark or service mark.
Copyright © 2019 Alliage S/A. All rights reserved.
The performance characteristics provided in this manual are for reference only and should not be
considered as guaranteed specications.

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TABLE OF CONTENTS
1. GENERAL INFORMATION........................................................................................................ 8
1.1. DEAR COSTUMER................................................................................................................................ 8
1.2. INDICATONS FOR USE ........................................................................................................................ 8
1.3. CONTRAINDICATION............................................................................................................................ 8
1.4. SYMBOLOGY........................................................................................................................................ 8
2. WARNINGS, PRECAUTIONS AND RECOMMENDATIONS ........................................................ 11
3. SYSTEM GENERAL DESCRIPTION .......................................................................................... 16
3.1. SYSTEM DESCRIPTION....................................................................................................................... 16
3.2. APPLICATION SPECIFICATION........................................................................................................... 16
3.2.1. Operation Principles ........................................................................................................................ 16
3.2.2. Signicant physical characteristics.............................................................................................. 16
3.2.3. User’s prole ..................................................................................................................................... 17
3.3. MAIN PRODUCT COMPONENTS........................................................................................................ 18
3.3.1. Light.................................................................................................................................................... 18
3.3.2 Arm ...................................................................................................................................................... 19
3.4. APPLIED PARTS.................................................................................................................................. 20
3.5. LABEL POSITIONING.......................................................................................................................... 20
3.6 SYSTEM REQUIREMENTS .................................................................................................................. 20
3.6.1. Place of Installation......................................................................................................................... 20
4. OPERATION ............................................................................................................................ 22
4.1 INITIAL PREPARATION....................................................................................................................... 22
4.2. ACTIVATING THE LIGHT ..................................................................................................................... 22
4.3 MOVEMENT OF THE HEADSTOCK .................................................................................................... 24
5. CLEANING AND DISINFECTION.............................................................................................. 26
6. PROBLEMS DIAGNOSTIC........................................................................................................ 28
6.1. PROBLEMS SOLUTION....................................................................................................................... 28
7. INSPECTION AND MAINTENANCE ......................................................................................... 30
7.1. PERIODIC INSPECTION ...................................................................................................................... 30
7.2. PREVENTIVE MAINTENANCE ............................................................................................................ 30
7.3. CORRECTIVE MAINTENANCE............................................................................................................. 31
7.4. ALLIAGE AUTHORIZED SERVICE NETWORK ................................................................................... 32
8. WARRANTY ............................................................................................................................ 34
8.1. WARRANTY TERMS............................................................................................................................ 34
8.2. WARRANTY PERIOD........................................................................................................................... 34
9. RULES AND REGULATIONS.................................................................................................... 36
10. TECHNICAL SPECIFICATIONS ................................................................................................. 38
10.1. EQUIPMENT CLASSIFICATION........................................................................................................... 38
10.2. DEVICE INFORMATION....................................................................................................................... 38
10.3. ENVIRONMENTAL CONDITIONS........................................................................................................ 39
10.4. LIGHT BEAM PROJECTION ................................................................................................................ 39
10.5 DENTAL LIGHT DIMENSIONS ............................................................................................................ 40

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11. ELECTROMAGNETIC COMPATIBILITY..................................................................................... 45
11.1. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS ........................................ 45
11.2. GUIDELINES AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY ...................................... 46

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1
GERENAL INFORMATION
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil

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1. GENERAL INFORMATION
1.1. DEAR COSTUMER
Congratulations on your excellent choice. When you buy ALLIAGE-quality equipment, you can be
sure of purchasing products with technology compatible with the best in the world in their class.
This manual oers you a general presentation of your equipment, describing important details that
can guide you in its correct use, as well as in solving minor problems that may eventually occur.
This manual must be read in full and kept for future reference.
1.2. INDICATONS FOR USE
The Dental Light is intended to assist in the treatment of the patient and in the performance of
dental practices, and is for dental use only.
1.3. CONTRAINDICATION
There are no known contraindications for this equipment.
1.4. SYMBOLOGY
The following symbols are used both throughout this manual and on the product.
Make sure you fully understand each symbol and follow the instructions that come with it.
Fragile, handle carefully Maximum stacking
Protect from rain Temperature limit
This side Up Protect from sunlight
Recyclable
Indicates that the product must
be taken to a special waste
collection site at the end of its
shelf-life. Applies to both device
and accessories
1

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Electrostatic sensitive (ESD)
devices Protection ground
Refer to the instructions manual Mandatory action
Caution Overall warning
Authorized representative in
European Union
Indicates that the equipment
complies with Directives 2011/65/
EU and 2015/863/EU on the
Restriction on the use of certain
hazardous substances in electrical
and electronic equipment.
Model Catalog number
Model number Serial number
Manufacturer Manufacturing date

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2
WARNINGS, PRECAUTIONS AND RECOMMENDATIONS
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil

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Overall warnings
During transportation
During the installation of the equipment
2. WARNINGS, PRECAUTIONS AND RECOMMENDATIONS
Read and understand all instructions contained in these instructions for use
before installing or operating this equipment.
Use the equipment only in perfect condition and protect yourself, patients
and others against possible hazards.
This equipment must be installed and operated by personnel familiar with the
necessary precautions.
The Dental Light has 2 dierent interactions with the user, namely:
- Identication label: Located on the side of the equipment;
- Safety symbols: Located in risk areas and on its identication tag;
Installation instructions can be found in the service manual, accessible only
to authorized technicians.
The equipment must be transported and stored, observing the following:
• Handle carefully to avoid falls, excessive vibrations and impacts;
• The arrows on the packaging must be pointing upwards;
• To handle the package as a single unit, consider the center of gravity indicator;
• Do not stack above the quantity indicated on the packaging;
• Do not walk or stand above the packaging
• Protect against sunlight, humidity, water and dust;
• Observe the temperature, pressure and relative humidity limits.
The equipment must be installed only by the authorized technician. This
technical procedure cannot be performed by the user.

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• The equipment must be installed only by authorized technicians.
• The service manual's recommendations regarding the mandatory existence of protective grounding
must be followed.
• Install the equipment in a location where it will not be in contact with humidity, water, plants
and animals.
• Install the equipment in a location where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, salts or corrosive products.
• This equipment is not designed for use in the presence of steams from ammable anesthetic
mixtures or nitrous oxide.
• Place any other external devices at least 1.5 meters away from the equipment, so that the patient
cannot touch any other external devices while they are being attended to.
• The recommendations in this manual for EMC should be followed. Communication equipment and
RF generating sources can aect the operation of the equipment.
• Equipment can cause radio interference or interrupt the operation of nearby equipment, making
it necessary to take mitigating measures, such as reorientation, relocation of the equipment or
shielding of the location.
In order to help ensure proper hygiene and protect against infectious diseases, before the rst use,
the equipment must be cleaned and disinfected according to the instructions contained in this manual.
• Under no circumstances can the patient operate the equipment.
• The patient must not touch any parts other than those specic for their treatment.
• The equipment must be operated only by qualied health professionals.
• To operate the equipment, operating personnel must:
- Read and understand the user manual
- Be familiar with the basic structure and functions of this equipment.
- Be familiar with the emergency situation protocols for this equipment.
- Be able to recognize irregularities in the operation of the equipment and implement the appropriate
measures, when necessary.
• This equipment was designed according to the electromagnetic compatibility standards, but in
very extreme conditions, it can cause interference with other equipment. Do not use this equipment
in conjunction with other devices that are very sensitive to interference or with devices that create
high electromagnetic disturbances.
• If this product is exposed to water, humidity or foreign substances, turn it o immediately and
contact an Alliage Authorized Service Center.
• In case of damage or defect, do not use the equipment and contact an Alliage Authorized Service
Center.
• Do not use the equipment if any of its compartments or parts are damaged, loose or have been
removed. Contact an Alliage Authorized Service Center and request repair or replacement of any
damaged, loose or removed cabinets or parts of the equipment before using it again.
• Do not touch the equipment or use it if it is being repaired or if the equipment's cabinets have
been removed.
• Do not open or remove any of the equipment's cabinets. No internal parts can be repaired by
the user.
• In case of falling or impact of moving parts causing their breakage, be careful when handling
Before using the equipment
While using the equipment

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them, there may be sharp parts.
• This equipment does not produce physiological eects that are not obvious to the operator.
• The operator cannot come into contact with the patient when in contact with accessible connectors.
• The operator cannot use tools to open the equipment.
• Turn o the equipment if it is not in use for a long time
• All parts that have been in contact with the patient should be cleaned and disinfected for each
new patient, in order to prevent the transmission of infectious agents that can cause serious illness.
• Perform cleaning and disinfection according to the instructions contained in this manual.
• Do not unplug the cable or other connections unnecessarily.
• Do not modify any part of the equipment.
If the equipment shows any abnormality, check if the problem is included in any item listed in the
"Problem diagnosis" topic of this user manual.
If it is not possible to solve the problem, turn o the equipment and contact an Alliage Authorized
Service Center.
• For each new patient, perform cleaning and disinfection procedures according to the instructions
contained in this manual.
Cross-contamination prevention
After using/ operating the equipment
Precautions in case of altered equipment operation
Adequate cleaning and disinfection measures should be taken to avoid cross-
contamination between patients, users and others.

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The manufacturer is NOT responsible for:
• The equipment being used for purposes other than those for which it was
designed.
• Damage caused to the equipment, the operator and/or patient, as a result of
incorrect installation and maintenance procedures that are not in accordance
with the operating instructions accompanying the equipment.
• Inadequate equipment operation.
This equipment must not be disposed of as household waste.
The Equipment's packaging consists of wood, cardboard, plastic and expanded
polyurethane (PU) which are 100% recyclable materials.
Alliage S/A aims to achieve an environmental policy to promote the supply of environmentally
conscious medical and dental products that continually minimize environmental impact and are
friendlier to the environment and human health. In order to maintain a minimal environmental
impact, observe the recommendations below:
• After installation, send recyclable materials for recycling process.
• During the life cycle of the equipment, turn it o when it is not in use.
• To prevent environmental contamination, the disposal of waste and consumables must follow the
usual procedure for biomedical waste.
Biomedical waste encompasses non-acute materials that may cause disease or suspicion of harboring
pathogenic organisms that must be stored in a yellow bag properly labeled with a biohazard symbol,
stored in a puncture-resistant, watertight container until collection and incineration.
In order to avoid environmental contamination or improper use of the equipment, when it is
unusable, it must be disposed of (in accordance with current legislation) in an appropriate place,
as the materials inside can contaminate the environment.
For the European Economic Area (EEA), this product is subject to Directive 2012/19/EU, as well
as the corresponding national laws. This directive requires that the product must be taken to a
special waste collection site at the end of its shelf-life. Applies to both the device and accessories.
Contact your salesperson if nal product disposal is required.
SIZES:
Main unit: 420 x 420 x 220mm/ MASS: Approximately: 2 Kg
Arm: 910 x 720 x 140mm/ MASS: Approximately: 10 Kg
Precautions for reducing environmental impact
Precautions in case of unusable equipment

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3
SYSTEM GENERAL DESCRIPTION
Alliage S/A Industrias Médico Odontológico
Telephone: [phone]
Rodovia Abrão Assed, Km 53 – Zip Code 14097-500 –Ribeirão Preto – SP –Brazil

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3.1. SYSTEM DESCRIPTION
3.2. APPLICATION SPECIFICATION
3. SYSTEM GENERAL DESCRIPTION
Focal dental reector with multi intensity light ranging from 8.000 to 35.000 Lux.
Composed by a new light emission system, using LED technology. This abbreviation is the acronym
for Light Emitting Diode, a totally dierent form of emitting light, when compared to conventional
devices with halogen light. Apart from being innitely longer lasting and with low electrical
consumption, the LED’s have become the most compact ergonomic devices, with easy installation
and transportation.
With rectangular light focus, it allows a wide illumination of the operative eld minimizing the need
for constant repositioning of the focus.
Head made of resistant material with a rotation of 620º.
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, 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.
Optical mirror protector in sturdy and transparent material protecting the mirror completely.
The LED is a light emitting diode, that is, a semiconductor electronic component that has the
property of transforming electrical energy into light.
This light emission is due to the fact that the electrons of the material's atoms are forced to change
orbits. When an electron jumps from one orbit to another, it is forced to emit energy to reach the
energy level of its new orbit and, under these conditions; the energy it discards appears in the
form of light.
The light emitted by the LED is cold due to the absence of infrared in the light beam.
Monofocal reector for dental use with multi-intensity light, ranging from 8,000 at 35,000 Lux and
multifaceted mirror with Multicoating treatment that generates numerous sources of cold white light.
3.2.1. Operation Principles
3.2.2. Signicant physical characteristics

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The Dental Light can be used by both male and female, with the minimum level of literacy, and
with the ability to read and understand images, symbols, icons, western characters (Arial font),
and alphanumeric characters. People who use the Dental Light may not have a degree of visual
imperfection for reading or seeing and an average degree of recent memory impairment, not being
clearly able to perform the activities and functions of the product correctly in the profession.
The user needs to be a healthcare professional that has been qualied and trained to perform
the activities, functions frequently used in the application of the Dental Light and its primary
operations functions.
3.2.3. User’s prole

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3.3. MAIN PRODUCT COMPONENTS
3.3.1. Light
*01 - Switch Shaft On/O
02 - Multi-sided glass mirror
03 - Protective cover
04 - Handles
05 - LED Heatsink
06 - Led lamp
07 - Hinged arm
07
02
05
03
06
01
04
* Optional items (Subject to commercial availability)

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3.3.2 Arm
*Supports for coupling in the
chair (allows the installation
of the articulated arm)
*Sleeve Kit - allows the
xation of the Light in oces
with 38mm column
*Articulated arm
*double bench articulated arm *Articulated arm with “orbital” movement
*Simple bench articulated
arm
*Support for oor/ cei-
ling coupling (allows
the installation of the
articulated arm)
* Optional items (Subject to commercial availability)

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3.4. APPLIED PARTS
3.5. LABEL POSITIONING
Illustrative picture
The following gure illustrates the location of the labels on the equipment.
This equipment does not have applied parts
3.6 SYSTEM REQUIREMENTS
3.6.1. Place of Installation
In order to meet safety standards, do not operate non-medical equipment, such
as personal computers, within the patient's area. Outside the patient's area,
the presence of non-medical equipment is acceptable, provided that approved
and certied computer equipment is used.
Computer equipment must be CE-approved and must comply with CE 60950-1:
2005 + AMD1: 2009 + AMD2: 2013 and low voltage 2014/35/EU and 2014/30/
EU EMC guidelines.
a
a