PRESE N OF MA - eagle-image.com

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1

Transcript of PRESE N OF MA - eagle-image.com

1

PRESE

GMDN

Model

Brand

Techn

CREA-

ANVIS

AlliaRodRibe

Tele CNP

770

ENTATIO

N: 44905 - D

: New IDA

: Dabi Atla

ical Respo

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SA Registe

age S/A Indovia Abrão

eirão Pretoephone: +5PJ: 55.979.

CINTEInternRua F 2900

Portug

000000592

ON OF MA

Dental digi

A

ante

onsible: R

714523

er: 101011

dustrias Méo Assed, Ko - SP - Bra55 (16) 351.736/0001-

ERQUAL –nacional, LdFran Pache0-374 Setúbgal

2 - Rev.: 13

Do

ANUAL

ital imaging

Ricardo Jos

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g sensor, i

sé Ravane

ntológico EP 14097-5

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2° And

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22

3

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 influential over any trademark, commercial trademark or service mark. New IDA 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 specifications.

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TABLE OF CONTENTS

DEAR CUSTOMER ............................................................................................................................................... 6 

USE INDICATION ................................................................................................................................................ 6 

CONTRAINDICATIONS ........................................................................................................................................ 6 

SYMBOLOGY ...................................................................................................................................................... 7 

WARNINGS, CAUTIONS, AND RECOMMENDATIONS ........................................................................................... 8 

DURING TRANSPORTATION AND STORAGE ............................................................................................................. 8 

BEFORE USING THE EQUIPMENT ............................................................................................................................. 9 

DURING THE INSTALLATION OF THE EQUIPMENT ................................................................................................... 9 

DURING THE EQUIPMENT USE ................................................................................................................................. 9 Prevention against cross contamination ........................................................................................................... 10 

AFTER USE / OPERATION OF THE EQUIPMENT ...................................................................................................... 10 

PRECAUTIONS IN CASE OF CHANGE IN THE PERFORMANCE OF THE EQUIPMENT ................................................ 10 

PRECAUTIONS FOR THE REDUCTION OF ENVIRONMENTAL IMPACT ..................................................................... 11 

PRECAUTIONS IN CASE OF DESTRUCTION OF THE EQUIPMENT ............................................................................ 11 

SYSTEM DESCRIPTION ...................................................................................................................................... 12 

SYSTEM STRUCTURE .............................................................................................................................................. 12 

INTRAORAL SENSOR ............................................................................................................................................... 13 

INTRAORAL SENSOR HOLDER ................................................................................................................................. 13 

COMPUTER SYSTEM ............................................................................................................................................... 13 Software requirements ...................................................................................................................................... 13 Hardware requirements .................................................................................................................................... 14 Electrical requirements ..................................................................................................................................... 14 Installation site .................................................................................................................................................. 14 

SOFTWARE ............................................................................................................................................................. 15 Software installation ......................................................................................................................................... 15 Main screen ....................................................................................................................................................... 20 Setting screen .................................................................................................................................................... 24 Odontogram ...................................................................................................................................................... 26 

CONSUMABLES ...................................................................................................................................................... 31 

LABELS .................................................................................................................................................................... 32 Identification ..................................................................................................................................................... 32 Safety ................................................................................................................................................................ 32 Refer to instruction manual .............................................................................................................................. 32 

INTRAORAL RADIOGRAPHY EQUIPMENT ............................................................................................................... 33 

SPECIFICATIONS AND TECHNICAL CHARACTERISTICS ............................................................................................ 34 General information .......................................................................................................................................... 34 Characteristics of the sensor ............................................................................................................................. 34 Environmental conditions for transportation and storage ................................................................................ 35 Conditions for installation and operation of the equipment ............................................................................. 35 

CERTIFICATIONS AND STANDARDS ................................................................................................................... 36 

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EMC / Security ................................................................................................................................................... 36 Usability ............................................................................................................................................................ 36 Software ............................................................................................................................................................ 36 Quality ............................................................................................................................................................... 36 

SYSTEM OPERATION ........................................................................................................................................ 37 

PREPARATION FOR USE.......................................................................................................................................... 37 

ACQUISITION OF RADIOGRAPHIC IMAGES ............................................................................................................. 38 Create a new registration of patient ................................................................................................................. 39 Opening a patient registration .......................................................................................................................... 40 Changing a patient registration ........................................................................................................................ 40 Sensor status ..................................................................................................................................................... 40 Process of image capturing ............................................................................................................................... 41 Images of the patient's registration .................................................................................................................. 42 Metric Calibration ............................................................................................................................................. 44 Precision of the measurement .......................................................................................................................... 47 

RECOMMENDATION FOR EXAMS ..................................................................................................................... 48 

CLEANING AND DISINFECTION .......................................................................................................................... 51 

MAINTENANCE ................................................................................................................................................ 52 

PERIODIC INSPECTION ............................................................................................................................................ 52 

PREVENTIVE MAINTENANCE .................................................................................................................................. 52 

CORRECTIVE MAINTENANCE .................................................................................................................................. 52 

ERROR DIAGNOSIS ................................................................................................................................................. 54 

CABLE REPLACEMENT ............................................................................................................................................ 55 

AUTHORIZED SERVICE NETWORK .......................................................................................................................... 58 

WARRANTY TERM .................................................................................................................................................. 58 Warranty period ................................................................................................................................................ 59 

ELECTROMAGNETIC COMPATIBILITY ................................................................................................................ 60 

GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY ................................................................... 61 

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EQUIPMENT IDENTIFICATION

DEAR CUSTOMER Congratulations for your excellent choice. When buying equipment with the "DABI ATLANTE" quality, you can be sure you purchased products with technology that is compatible with the best in the world from its class. This manual offers 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 New IDA is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals, observing the instructions included in this manual. CONTRAINDICATIONS

The intraoral dental digital imaging sensor New IDA is contraindicated to patients with temporomandibular dysfunction that limited mouth opening and who have anatomical characteristics that prevent their use as a low palate.

The protective plastic covers contain polyvinyl chloride (PVC) and should not be use by people with allergies to polyvinyl chloride (PVC) or substances used in the manufacturing process of the same such as bisphenol A, adipic polyester, propylene glycol compound and ethylhexyl maleate

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13

INTRAORAL SENSOR

The Intraoral dental digital imaging sensor New IDA uses a sensor that employs

the associated technologies from CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber 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 2.0 connection (Universal Serial Bus).

INTRAORAL SENSOR HOLDER

The intraoral sensor holder consists of a base where the sensor can be placed

when it is not in use. The intraoral sensor holder can be screwed close to the computer system using

the two supplied screws or other mounting material. Alternatively, it may be glued to a uniform surface using the supplied double-

sided adhesive tape.

COMPUTER SYSTEM

Software requirements

For the correct performance of the New IDA 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 offers 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 New IDA software will be

automatically installed, in shape of prerequisites, during the installation of the application, offering more speed and convenience to the user.

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Degree flammaboxygen OperatioInput VoInput CuPower CCable le

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ent Classification classcation classcation of thecation of theon Against on Against

of applicatible anestheor nitrous oon Mode oltage urrent Consumptioength

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dimension number (Melogy vel resolution

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cation s according s according e Equipmene product foElectrical SHarmful Wa

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trias Médic(16) 3512-a Abrão AsSP - Brasil

to ANVISAto CE

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Environmental conditions for transportation and storage

Room temperature range for transportation and storage

+4ºC to +40ºC

Relative humidity range for transportation and storage

< 85% RH

Atmospheric pressure band 797 hPa to 1013 hPa (598 mmHg to 760 mmHg)

Conditions for installation and operation of the equipment

Operating room temperature band +10ºC to +30ºC Operating relative humidity range (non-condensing)

< 75% RH

Atmospheric pressure band 797 hPa to 1013 hPa (598 mmHg to 760 mmHg)

Operating altitude ≤ 2000 m

36

CERTIFICATIONS AND STANDARDS

This product bears CE mark in accordance with the provisions of Council Directive 93/42/ EC of June 14, 1993 on medical devices as amended by Directive 2007/47/EC of September 5, 2007.

The Intraoral Dental Digital Imaging Sensor, along with the components of his system, have been evaluated and are conformed to the international EMC, safety and quality standards listed below, among others:

EMC / Security

EN 60601-1: 2006 / A1: 2013 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

EN 60601-1-2: 2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

Usability

EN 60601-1-6: 2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

EN 62366: 2008 - Medical devices - Application of usability engineering to medical devices.

Software

EN 62304: 2006 / AC: 2008 - Medical device software - Software life-cycle processes.

Quality

EN ISO 13485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes

EN ISO 14971: 2012 - Medical devices - Application of risk management to medical devices.

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47

n

7

48

RECOMMENDATION FOR EXAMS

The radiographs must be performed only when there's a diagnosis expectation that will affect the treatment of the patient. The dentist shall consider the benefits of getting radiographs against the risk of exposing the patient to radiation.

Due to the effects of radiation accumulation over time, all efforts must be done to minimize the patient exposure.

Use lead apron and thyroid collar, Use pediatric profile or low usage and select the lowest permissible time of

exposure. There may be clinical circumstances for which a radiography is indicated, but a

diagnosis image can't be obtained. For example, the patient may not be able to cooperate with the dentist.

TYPE OF CONSULTATION

PATIENT AGE AND STAGE OF DENTAL DEVELOPMENT1 Children with primary dentition (before the eruption of the first permanent tooth)

Children with transitory dentition (after the eruption of the first permanent tooth)

Teenager with permanent dentition (before the eruption of the third molars)

Adult toothed or partially edentulous

Adult, Edentulous

New Patient * being evaluated for oral

diseases

Individualized radiographic exam which consists of periapical / Occlusal view and/or posterior bitewings if the proximal surface can't be viewed or probed. Patients with no indication of the disease and with open proximal contacts may not require a radiography

Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images.

Individualized radiographic exam which consists of posterior bitewings with panoramical exam or posterior bitewings and selected periapical images. A complete intraoral radiography exam from the mouth is preferable when the patient has clinical evidence of generalized oral disease or an extensive record of dental treatment.

Individualizes radiography exam, based on signs and clinical symptoms.

Patient follow-up* with decay or increased

risk of decay**

Posterior bitewing exam in intervals of 6-12 months if the proximal surfaces can't be visually examined or with a probe

Posterior bitewing exam in intervals of 6-18 months

Non-applicable

Patient follow-up* without decay or

increased risk of decay**

Posterior bitewing exam in intervals of 12-24 months if the proximal surfaces can't be visually examined or with a probe

Posterior bitewing exam in intervals of 18-36 months

Posterior bitewing exam in intervals of 24-36 months

Non-applicable

Patient follow-up* with periodontal disease

Clinical judgment related to the need and type of radiographic images for the evaluation of the periodontal disease. The image can consist, but not be limited to, bitewing and/or periapical images from areas where the periodontal disease (except non-specific gingivitis) can be clinically demonstrated.

Non-applicable

Patient (New and Return) A clinical judgment about the need A clinical It is usually not indicated for

for

de

den

Pcircu

bpr

implcranrest

cperio

rem

r growth moand dentof

evelopment,evaluation otal/skeletal

Patient with umstances ibut not limitroposed or eant, other d

niofacial pattoration / encare, treatmeodontal disemineralizatio

decay

* Clinicnot lim A. Hist1. Prev2. Histo3. Fam4. Post5. Rem6. Implimplant B. Clin 1. Cli

onitoring facial , and/or of the relations

other including, ted to, existent dental and thologies, ndodontic ent for eases and on of the y

This reapplic It is threason

cal situatimited to:

tory of povious perioory of pain

mily history t-surgery e

mineralizatiant present placemen

nical posit

nical evid

and type ofevaluation growth aevaluation dentofacial

Clinical judcontrol of th

ecommenable to ev

he dentist nably poss

ons in wh

sitive discodontal or or traumaof dental a

evaluation fon monitornce, patholnt

tive - Sign

dence of

f radiographand/or mon

and develof dental relations.

gment abouhese conditio

ndation isvery patien

responsisible) to m

hich the ra

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a abnormalitifor healingring logy relate

s and Sym

periodon

ic images foitoring of thlopment oand skeleta

ut the need ons

subjectednt.

bility to fominimize t

adiograph

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ies g

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mptoms

ntal 14. P

or he or al

judgmenthe netype radiograimages evaluatioand/or monitoringrowth dentofacdevelopmevaluatiodental skeletal relationsPanoramperiapicato evaludevelopmthe third

and type of

d to the c

ollow the he exposu

is indicat

nt

ous implan

Pain or ATM

nt about ed and

of phic

for on

ng of the and

cial ment or on of

and

s. mic or al exam uate the ment of molars

gmaraere

f radiograph

clinical jud

ALARA pure of the

ed include

ts or evalu

M dysfunct

growth amonitoring. about the radiographic evaluation ofrelations.

hic images f

dgment a

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es, but it's

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tion

49

and deveA clinical jneed and

imagesf dental and

for evaluatio

and is not

as low as

s

9

elopment judgment type of

s for d skeletal

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50

disease 2. Big or deep restoration 3. Injury from deep cavity 4. Crooked or broken teeth 5. Swelling 6. Evidence of dental or facial trauma 7. Teeth mobility 8. Fistula 9. Clinical suspect of sinus pathology 10. Growth anomalies 11. Oral involvement in the known or suspicious systemic disease 12. Neurological positive findings in the head or neck 13. Evidence of strange objects

15. Facial asymmetry 16. Pillar for prosthesis partially removable or fix 17. Unexplained bleeding 18. Inexplicable teeth sensibility 19. Unusual eruption, spacing or teeth migration 20. Morphology of the unusual tooth, calcification or color 21. Inexplicable absence of teeth 22. Clinical Acid Erosion 23. Peri-implanting

The factors that increase the risk for caries can be available using the ADA forms for caries risk assessment (0 - 6 years old and older than 6 years old).

1U.S. Department of Health and Human Services. Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure. Available in http://www.ada.org/~/media/ADA/Member%20Center/FIles/Dental_Radiographic_Examinations_2012.ashx. Accessed on November 2, 2015. 2The American Academy of Pediatric Dentistry. Guideline on Prescribing Dental Radiographs for Infants, Children, Adolescents, and Persons with Special Health Care Needs. Available in http://www.aapd.org/media/policies_guidelines/e_radiographs.pdf. Accessed on November 2, 2015. 3U.S. Department of Health and Human Services. Pediatric X-ray Imaging Available at: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm. Accessed on November 2, 2015.

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54

ERROR DIAGNOSIS In the case of problems with the functioning of your sensor, verify the following:

Symptoms Diagnosis and solutions

Red status of the sensor, indicating that it is not connected

The sensor was not recognized by the computer or it is off. - Verify if the USB cable is properly connected to the computer - Restart the computer - Verify if the drivers of the sensor are correctly installed.

Red status of the sensor, indicating that it is not connected And start capture button doesn't appear

Patient folder was not selected

Blue status of the sensor and there's no image.

- Make sure the sensor is activated (button "Start capture" before the X-Ray shots. - Verify the correct performance of the generator. - Make sure the sensor surface is oriented to the x-rays source and that is correctly aligned.

Green status of the sensor and there's no image.

- Verify the correct performance of the X-Ray generator. - Make sure the active sensor surface is oriented to the x-rays source and that is correctly aligned.

Error "TransfersThread() - pre-capture(0) SafeHandle was closed"

Fail in USB communication during the capture of the sensor. - Verify if the USB cable shows any damage indicative - Verify USB connection with the computer - Verify if the USB port of the computer has the capacity to supply enough power for the proper operation of the sensor.

Error "New IDA has stopped working A problem made the program stop working correctly. Windows will close the program and will notify if there's an available solution"

Fail in USB communication during the setting of the sensor. - Verify if the USB cable shows any damage indicative - Verify USB connection with the computer - Verify if the USB port of the computer has the capacity to supply enough power for the proper operation of the sensor.

Fail in RAM memory - Verify the RAM memory of the computer

WarningbetweenNew calibratifiles bplease i

Error "TnecessafollowingFramew

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58

AUTHORIZED SERVICE NETWORK

All services performed in the Alliage equipment must be done by an Authorized

Technical Assistant, because, otherwise, they won't be covered by the warrant. If you need to request electrical schemes and/or components specifications that are

not declared in the user manual, use the Alliage Customer Attendance Service to make the request.

Telephone: +55 (16) 3512-1212 E-mail: [email protected] Address: Rodovia Abraão Assed, Km 53 - Recreio Anhangüera - Ribeirão Preto-SP/ Brasil CEP 14097-500

WARRANTY TERM

The Warranty Term, in three copies, must the properly filled by the Alliage

Authorized Technical Assistant. One of the copies, already marked, will be delivered to

the owner for confirmation of the equipment under warranty. One of the remaining

copies will stay with the distributor and the other one will be sent to the manufacturer.

The warranty is limited to the repair or replacement of manufacturing defect parts

and it doesn't include the repair of defects caused by:

- Damage or loss caused by improper use or abuse;

- Damage or loss caused by non-compliance of use and maintenance

instructions.

- Damage or loss caused by acts of nature or catastrophes like fire,

earthquakes, floods, lightning, etc.

- Damage or loss caused by a failure in compliance of the specified conditions

for the system, such as improper installation, improper environment

conditions, etc.

- Damage or loss caused by the use outside the territory where the system was

originally sold;

- Damage or loss caused by Malware (malicious software such as virus, worm,

among others that can damage computers);

- Fall or crash;

59

- inappropriate storage;

- Technical service performed by nonauthorized people by Alliage.

Warranty period

The manufacturer offers a warranty of 12 (twelve) months starting from the

installation date, against parts defects, raw materials, and manufacturing of its

hardware products. In the case of defects occurred and notified during the warranty

period, replacement parts and labor force will be supplied for the replacement or the

items covered by the warranty.

THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY OTHER

WARRANTY, EXPRESS OR IMPLIED, INCLUSIVE BUT NOT ONLY THE

WARRANTIES IMPLIED FOR COMMERCIALIZATION OR SUITABILITY TO A

PARTICULAR PURPOSE AND THE ONES RESULTING OF A TRANSACTION OR

COMMERCIAL USE.

The express warranty is not applicable to the following items: disposable parts,

defect or damage caused by negligence, improper use, operator mistake, inappropriate

installation, changings or non-specified operations of the product from the manufacturer

hardware.

PERFORMING THE CONDITIONS STATED ABOVE, THE MANUFACTURER

WON'T BE RESPONSIBLE BY ANY DAMAGE, DIRECT OR INDIRECT,

IRRELEVANT OR SIGNIFICANT, THAT CAN OCCUR AND REGARDLESS THE

LEGAL THESIS PROPOSED, INCLUDING RESPONSIBILITY STRICT AND

NEGLIGENCE.

At no time the manufacturer will be responsible by any of the following

circumstances:

- Performance, failure or interference from any net used by the Client;

- Performance, failure or interference caused by any equipment or third-party

software;

60

ELECTROMAGNETIC COMPATIBILITY

The Intraoral Dental Digital Imaging Sensor is intended for use in the electromagnetic environment specified below. Buyer or user should ensure that it is used in such an environment.

The Intraoral Dental Digital Imaging Sensor is suitable for use in a

professional health care environment, not including areas where there are sensitive equipment or sources of intense electromagnetic disturbances, such as the RF shielded room of an imaging system magnetic resonance imaging, in operating rooms near active AF surgical equipment, electrophysiology laboratories, armored rooms or areas where short wave therapy equipment is used. The following tables provide information on compliance of the equipment according to the standard EN 60601-1-2:2015. GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC EMISSIONS Emission Essays Conformity Electromagnetic environments -

guidelines

RF emissions CISPR 11 Group 1

The Intraoral Dental Digital Imaging

Sensor uses RF energy only for its

internal functions. Therefore, your RF

emissions are very low and probably

will not cause any interference in

nearby electronic equipment.

RF emissions CISPR 11 Class B The Intraoral Dental Digital Imaging

Sensor is suitable for use in all

establishments other than domestic and

those directly connected to the public

low-voltage power supply network that

supplies buildings used for domestic

purposes.

Harmonic emissions

IEC 61000-3-2 Not applicable

Voltage fluctuation/

Scintillation Emissions

IEC 61000-3-3

Not applicable

61

GUIDANCE AND DECLARATION FOR ELECTROMAGNETIC IMMUNITY

Phenomenon Basic standard of

EMC

Immunity test level Level of conformity

Electrostatic discharge IEC 61000-4-2

±8 KV contact

± 2 KV, ± 4 KV, ± 8 KV,

± 15 KV air

±8 KV contact

± 2 KV, ± 4 KV, ± 8 KV,

± 15 KV air

Radiated RF EM fields IEC 61000-4-3

3 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

3 V/m

80 MHz – 2.7 GHz

80 % AM at 1 kHz

Proximity fields from RF

wireless communications

equipment

IEC 61000-4-3 See table See table

Electrical Fast / Transients

bursts IEC 61000-4-4

± 1 kV

100 kHz repetition

frequency

± 1 kV

100 kHz repetition

frequency

Conducted disturbances

induced by RF fields IEC 61000-4-6

3 V

0.15 MHz – 80 MHz

6 V m in ISM bands between 0.15MHz e 80MHz

80 % AM at 1 kHz

3 V

0.15 MHz – 80 MHz

6 V m in ISM bands between 0.15MHz e 80MHz

80 % AM at 1 kHz

Rated power frequency

magnetic fields IEC 61000-4-8

30 A/m

50 Hz or 60 Hz

30 A/m

50 Hz or 60 Hz

Tes

freque

(MH

385

450

710

745

780

810

870

930

172

184

197

245

524

550

578

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390

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470

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704

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800

9600

0

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1700

19945

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traoral Dea-oral medclusive denence loss o

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TRA 400

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13, 17 Band

M 800/900,

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CDMA 850,

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1800; CDMA

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; LTE 1, 3, 4,

and, UMTS

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ental Digitical image

ntal use onof commun

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217

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Hz

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7 Hz

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tions equipm

Maximum

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is intendee and oral isturbancedevice an

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62

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