SAEVO Slim User manual
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PRESENTATION OF MANUAL
GMDN: 44905 - Dental digital imaging sensor, intraoral
Technical Name: X-ray imaging scanner
Trade Name: Sistema Radiográco Digital Intraoral
Model: Saevo Slim
Brand: Saevo
Technical Responsible: Daniel R. de Camargo
CREA-SP: 5062199650
ANVISA Register: 10101139029
Document originally written in Portuguese.
Alliage S/A Indústrias Médico Odontológica
Rodovia Abrão Assed, Km 53 + 450m - CEP 14097-500
Ribeirão Preto - SP - Brasil
Tel: +55 (16) 3512-1212
77000001680 - Rev.: 01 - May/22
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TRADEMARKS
All terms stated in this manual that are from known trademarks, commercial trademarks or service
marks were properly labeled as such. Other products, services or terms that are mentioned in this
manual can be trademarks, commercial trademarks or service marks of their respective owners.
The Alliage S/A makes no claim in relation to these trademarks. The use of a term in this manual
must not be considered as inuential over any trademark, commercial trademark or service mark.
Saevo Slim is a commercial trademark from Alliage S/A.
Microsoft, Windows and .NET Framework are commercial trademarks of Microsoft Corporation in the
United States and other countries.
GNU LESSER is a trademark from Free Software Foundation, Inc.
Copyright © 2017 Alliage S/A. All Rights Reserved.
The performance characteristics presented in this manual are only for reference and mustn't be
considered as secured specications.
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TABLE OF CONTENTS
06 DEAR CUSTOMER
06 USE INDICATION
06 CONTRAINDICATION
07 SYMBOLOGY
09 WARNINGS, CAUTIONS, AND RECOMMENDATIONS
09 DURING TRANSPORTATION AND STORAGE
10 BEFORE USING THE EQUIPMENT
10 DURING THE INSTALLATION OF THE EQUIPMENT
10 DURING THE EQUIPMENT USE
11 PREVENTION AGAINST CROSS CONTAMINATION
11 AFTER USE / OPERATION OF THE EQUIPMENT
11 PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT
11 PRECAUTIONS FOR THE REDUCTION OF ENVIRONMENTAL IMPACT
12 PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT
13 SYSTEM DESCRIPTION
15 INTRAORAL SENSOR
15 HOLDER FOR INTRAORAL SENSOR
15 COMPUTER SYSTEM
15 SOFTWARE REQUIREMENTS
16 HARDWARE REQUIREMENTS
16 ELECTRICAL REQUIREMENTS
17 INSTALLATION SITE
17 SOFTWARE
17 SOFTWARE INSTALLATION
22 MAIN SCREEN
23 INTERFACE ICONS
27 SETTING SCREEN
28 ODONTOGRAM
33 CONSUMABLES
34 LABELS
35 INTRAORAL RADIOGRAPHY EQUIPMENT
35 SPECIFICATIONS AND TECHNICAL CHARACTERISTICS
35 GENERAL INFORMATION
36 CHARACTERISTICS OF THE SENSOR
36 ENVIRONMENTAL CONDITIONS FOR TRANSPORTATION AND STORAGE
36 CONDITIONS FOR INSTALLATION AND OPERATION OF THE EQUIPMENT
37 SYSTEM OPERATION
37 PREPARATION FOR USE
40 ACQUISITION OF RADIOGRAPHIC IMAGES
41 CREATE A NEW REGISTRATION OF PATIENT
42 OPENING A PATIENT REGISTRATION
42 CHANGING A PATIENT REGISTRATION
43 SENSOR STATUS
43 PROCESS OF IMAGE CAPTURING
45 IMAGES OF THE PATIENT'S REGISTRATION
46 METRIC CALIBRATION
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49 PRECISION OF THE MEASUREMENT
50 RECOMMENDATION FOR EXAMS
54 CLEANING AND DISINFECTION
55 MAINTENANCE
55 PERIODIC INSPECTION
55 PREVENTIVE MAINTENANCE
55 CORRECTIVE MAINTENANCE
56 ERROR DIAGNOSIS
58 CABLE REPLACEMENT
60 AUTHORIZED SERVICE NETWORK ALLIAGE
60 WARRANTY
61 ELECTROMAGNETIC COMPATIBILITY TABLES (EMC)
61 GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS
62 GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY
TABLE OF CONTENTS
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EQUIPMENT IDENTIFICATION
DEAR CUSTOMER
Congratulations for your excellent choice. When buying equipment with the "Saevo" quality, you
can be sure you purchased products with technology that is compatible with the best in the world
from its class.
This manual oers you a general presentation of your equipment, describing important details that
can guide you in its correct use, as well as in the solution of small issues that can eventually occur.
There is no need of any additional training besides its own reading.
This manual must be read on the whole and preserved to future consultations.
USE INDICATION
The Intraoral dental digital imaging sensor Saevo Slim is aimed at the acquisition of intra-oral me-
dical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled
by trained and qualied health professionals, observing the instructions included in this manual.
CONTRAINDICATION
The Intraoral dental digital imaging sensor Saevo Slim is contraindicated for patients with tempo-
romandibular dysfunction who limit mouth opening.
Protective plastic covers contain polyvinyl chloride (PVC) and should not be used by persons with
polyvinyl chloride (PVC) allergies or substances used in the manufacturing process of the same,
such as bisphenol A, adipic polyester, Propylene glycol compound and ethylhexyl and who have
anatomical characteristics that prevent their use as a low palate.
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Use the icons above to identify the symbology of your equipment.
SYMBOLOGY
Fragile, handle with care Applied parts BF type
Keep dry Equipment Class II
This side up Attention
Keep away from sunlight General warning
Maximum stacking Mandatory action
Temperature limit Temperature limit
Humidity limit USB connection
Recyclable Catalog number
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Do not re-use Serial number
Indicates that the product must be
taken to a special waste collection
site at the end of its lifespan.
Applies to the device and to the
accessories.
Part Number
IP00 This product is not protected
against harmful water inltrations
and particulate matter.
Indicates that the product has
passed an evaluation, and that
standards or regulations develo-
ped for the product category have
been observed in its design / ma-
nufacture / placing on the market.
Manufacturer Manufacturer
Model
SYMBOLOGY
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WARNINGS, CAUTIONS, AND RECOMMENDATIONS
Read and understand the instructions contained in these instructions for use
before install or operate this equipment.
Use the equipment only if in perfect conditions and protect yourself, patients
and third parties against possible dangers.
Operation of this device may be dangerous for the patient and the operator
unless safe exposure factors and operating instructions are observed. Personal
protective equipment should be used with this device.
This equipment must be installed and operated by personal acquainted to the
necessary precautions to avoid excessive exposure to primary and secondary
radiation.
The Saevo Slim has three dierent interactions with the user. They are:
- Identication label: Placed in the lower part of the product package;
- Security symbology: Placed in the upper part of the sensor on its identication;
- Image acquisition software: Found installed with a computer where the
sensor is connected.
DURING TRANSPORTATION AND STORAGE
The equipment must be shall be carried and stored according to the following:
• Handle with care to avoid falls and impacts.
• The arrows on the package must be pointing upwards.
• Don't stack items above the quantity indicated on the packaging
• Protect against sunlight, humidity, water and dust.
• Observe the limit of temperature, pressure and relative humidity
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BEFORE USING THE EQUIPMENT
To help and ensure a proper hygiene and to protect against infectious diseases, before rst use, the
equipment must be cleaned and disinfected according to the instructions enclosed in this manual.
DURING THE INSTALLATION OF THE EQUIPMENT
• Put the equipment in a place where it won't be in contact with humidity or water.
• Install the unity in a place where it won't be damaged by pressure, temperature, humidity, direct
sunlight, dust, salt or corrosive products.
• Operators should follow all radiation protection guidelines for pregnant or suspected pregnancy
patients, including the use of abdomen and thyroid protection.
• The equipment must not be subjected to excessive vibration or shock (including during transpor-
tation and handle).
• This equipment was not designed for use in presence of vapors from ammable anesthetics mix-
tures or nitrous oxide.
• The recommendations of this manual must be followed regarding the EMC. Communication equi-
pment and sources that generate RF can aect the performance of the equipment.
DURING THE EQUIPMENT USE
• The equipment must be operated only by qualied healthy professionals including safeguard
knowledge against excessive exposure to radiation.
• The equipment was manufactured to resist continuous and intermittent operation; therefore,
follow the cycles described in the Owner's Manual.
• X-Ray exposure can cause damage to human body cells. It is recommended that no one stays in
the radiographic examination room unless the containment of the patient is necessary. In this case,
this person must be properly protected against ray emissions.
• The equipment was projected according to the electromagnetic compatibility standards, but in
very extreme conditions, it can cause interference with other equipment. Don't use this equipment
along with other devices that are sensitive to interference or with devices that create high elec-
tromagnetic disturbances.
Proper hygienic measures must be taken to avoid cross contamination among
the patient, users and other people.
The manufacturer assumes NO liability:
• If the equipment is used for purposes other than those for which it was
designed.
• For damages caused to the equipment, operator and/or patient as result of
incorrect installation and maintenance procedures that are not in compliance
with the operation instructions that comes with the equipment.
• For inappropriate operation of the equipment.
WARNINGS, CAUTIONS, AND RECOMMENDATIONS
11
PREVENTION AGAINST CROSS CONTAMINATION
• To help to prevent the cross contamination among the patients, it is mandatory the use of dis-
posable protective plastic covers.
• The covers must be properly disposed of for each new patient.
• The protective plastic cover must cover the sensor and at least 10 cm of the USB cable.
• Don't ever use damaged protective plastic covers.
AFTER USE / OPERATION OF THE EQUIPMENT
• Turn o the equipment when it is not being used for an extended period.
• The protective plastic covers must be disposed and the positioners, if used, must be sterilized for
each new patient to avoid the transmission of infectious agents that can cause serious conditions.
• Perform the cleaning and disinfection according to the instructions contained in this manual.
• Don't modify any part of the equipment.
In case of damage or defect, do not use the equipment and contact an Alliage
Authorized Technical Assistance.
PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT
If the equipment presents any abnormality, verify id the problem is related to any item listed in
the topic: "Error Diagnosis" of this user manual.
If it is not possible to solve the problem, turn o the equipment and disconnect the cables
PRECAUTIONS FOR THE REDUCTION OF ENVIRONMENTAL IMPACT
Alliage S/A aims to reach an environmental politics to promote the supply of medical and dental
products environmental conscious that continuously minimize the environmental impact and that are
more friendly to the environment and to the human health.
To keep a minimum impact on the environment, observe the following recommendations:
• After installation, forward the recyclable materials for the recycling process.
• During the life cycle of the equipment, turn it o when it is not being used.
• To prevent environmental contamination, the disposal of the protective plastic covers and other
consumables must be according to the normal procedure of the dental oce for biomedical waste.
The biomedical waste comprises nonhigh materials susceptible to cause diseases or suspect for housing
pathogenic organisms that must be stored in a yellow bag properly labeled with the symbol of biological
hazard, stored in a container resistant to perforation, tight and even recollection and incineration.
The packaging1of the Saevo Slim is composed of cardboard and plastic, which
are 100% recyclable materials.
1DIMENSIONS: 185 x 160 x 71,5 mm /WEIGHT: Approximately: 100g
WARNINGS, CAUTIONS, AND RECOMMENDATIONS
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PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT
To avoid environmental contamination or inappropriate use of the Saevo Slim when it is destroyed,
they must be disposed of (according to the current legislation) in an appropriate place, since the
existent materials inside it can contaminate the environment.
To the European Economic Area (EEA), this product is subject to the Directive 2012/19/EU, ass well
as to the correspondent national laws. This directive requires that the product must be taken to a
special waste collection site at the end of its lifespan. Applies to the device and to the accessories
Contact the retailer if the nal disposition of the product is necessary.
This equipment must not be disposed of as domestic waste.
WARNINGS, CAUTIONS, AND RECOMMENDATIONS
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SYSTEM DESCRIPTION
PARTS THAT ACCOMPANY THE PRODUCT
01 - Sensor Saevo Slim
02 - Saevo Slim holder
03 - Installation ash drive (Software, Drivers, and Manuals)
04 - Capa de silicone
01 02 03
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The Saevo Slim Sensor can be marketed in white or black. (Subject to com-
mercial availability).
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ACCESSORIES THAT DON'T ACCOMPANY THE PRODUCT
SYSTEM DESCRIPTION
*01 - Positioning kit
02 - Protective plastic cover
* Optional items
02
01
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INTRAORAL SENSOR
The Intraoral dental digital imaging sensor Saevo Slim uses a sensor that employs the associated
technologies from CMOS (Complementary Metal-Oxide-Semiconductor), protective optical ber
and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human
arch and its structures. The acquisition process is made by positioning the sensor inside the mouth,
behind the structure you want to perform the exam. The structure must be exposed to an x-ray
dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons
into a digital sign and transfers it to a computer through USB connection (Universal Serial Bus).
HOLDER FOR INTRAORAL SENSOR
The intraoral sensor support consists of a base where the sensor can be placed when it is not in use.
The intraoral sensor support can be screwed close to the computer system using the two screws
provided or other mounting material.
Alternatively, the support can be glued to a uniform surface, for example, using the required
double-sided adhesive tape.
COMPUTER SYSTEM
The captured digital images are transferred to a computer system via a USB port.
SOFTWARE REQUIREMENTS
For the correct performance of the Saevo Slim software, some basic software described below is
necessary:
.Net Framework 4.5.1: The NET Framework is essential to run several programs that were developed
through the use of this technology from Microsoft. This framework oers a series of resources for
the agile and robust development of applications. The 4.5.1 version requires the Windows Vista SP2
or superior and it's included in Windows 8.1 and in Windows Server 2012 R2.
wkhtmltopdf 0.12.3.2: It's an open-source command line tool (LGPLv3) to render HTML to PDF using
the rendering mechanism from Qt WebKit. It works completely "headless" and it doesn't require an
exhibition service or exhibition.
The required software for the performance of the Saevo Slim software will be automatically instal-
led, in shape of prerequisites, during the installation of the application, oering more speed and
convenience to the user.
SYSTEM DESCRIPTION
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Operational System Windows 7 (x86 e x64) - Home, Starter, Pro
Windows 8 (x86 e x64) - Pro
Windows 8.1 (x86 e x64) - Pro
Windows 10 (x86 e x64) - Home, Pro
CPU Intel i3 3.0 Ghz or superior
HDD 500 GB
RAM 2GB DDR2 SDRAM
Monitor 1024x768
USB connector 2 x USB 2.0 – 500mA
The computer must be EC approved and compliant with IEC 60950-1: 2005 +
AMD1: 2009 + AMD2: 2013 and the Low Voltage Directive 2014/35 / EU and
EMC 2014/30 / EU.
In addition, to help ensure optimum performance, make sure that all installed
programs are virus-free and have been properly tested so that you do not
inuence the image acquisition software after installation.
Don't use USB ports available in keyboards or in the front or lateral side of
the computer. These connections are frequently unable to deliver sucient
power for the proper operation of the sensor.
It is recommended the execution of regular backup in the les and patient data
to avoid record loss in case of failure of the computing system.
HARDWARE REQUIREMENTS
The computer system must meet the following requirements.
ELECTRICAL REQUIREMENTS
The Saevo Slim doesn't require an external power supply since its power is supplied through the
USB connection of the computer and it has approximate consumption of 300mA.
SYSTEM DESCRIPTION
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Place your computer and video monitor outside the patient area, ensuring that there's enough
space for proper ventilation.
Preferably, use the monitor in 4:3, with full HD features and place the screen to avoid direct light
or reexes that can make dicult the visualization of the images.
Place the sensor next to the patient, with a minimum distance of 1.5 meter from the computer. Only
the sensor and medical equipment can be inside the patient area.
To meet the safety regulations, don't operate non-medical equipment like
personal computers inside the patient area. Outside the patient area, it's ac-
ceptable the presence of non-medical equipment as long as it's used computer
equipment approved and certied by IEC 60950-1:2005 + AMD1:2009+AMD2:2013
INSTALLATION SITE
SOFTWARE INSTALLATION
Insert the sensor in the USB port of the computer.
SOFTWARE
The dental image management software interfaces with the Saevo Slim system and the user, making
it possible to view, improve, store, send, print, among other functions.
Connect the ash drive that accompanies the Saevo Slim in the USB port, open the device and click
on the le setup_2_0_0_X
SYSTEM DESCRIPTION
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Select the desired language and click on OK
Read and understand the End User License Agreement and, if you accept, click on I accept the
terms of the Contract.. Click Next.
Select the dialog box if you want to create an icon on Desktop and click Next.
SYSTEM DESCRIPTION
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Click Install to begin the installation process.
Setup will install .NET 4.5.1
Setup will install the necessary tools to generate reports. Click "I Agree" to accept the terms of
the software.
SYSTEM DESCRIPTION
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Click "Install"
Wait for the end of installation and click "Close"
Setup will install the USB driver. Press Install to begin the installation process.
SYSTEM DESCRIPTION
Table of contents
