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 Radiográco 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: [phone]
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 inuential 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 specications.

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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 oers 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 qualied 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 inltrations
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 dierent interactions with the user. They are:
- Identication label: Placed in the lower part of the product package;
- Security symbology: Placed in the upper part of the sensor on its identication;
- 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 aect the performance of the equipment.
DURING THE EQUIPMENT USE
• The equipment must be operated only by qualied 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