BRASSELER USA GEM Manuel utilisateur

DIGITIAL X-RAY SENSORS

INSTRUCTIONS FOR USE

Introduction

Essential Performance 3

Product Description 3

Indications for Use 3

Device Overview 4

Prociency with the GEM Digital Sensor System 4

Conventions Used in the Manual 5

Installation, Care, and Maintenance

Description of Product Symbols 5

Hardware Requirements 5

Installing the Brasseler GEM Digital Sensor System 6

Installing Device Driver for Sensor 6

Connect a GEM Sensor 6

Adjusting the X-Ray Source 6

Conformance to Standards 6

Safety Considerations 7

X-Ray Protection 7

Mains Location 7

Prevention of Cross-Contamination 7

Sensor Inspection 7

Disposal 7

X-Ray Generator Settings 7

Proper Care of the Brasseler GEM Digital Sensor System 8

Image Quality Assurance 8

Appendices

Appendix A - EMC Information 9

Appendix B - Specications and Standards 14

Appendix C - Product Symbols 15

Appendix D - Care Instructions 19

Handling 19

Cleaning 19

Examples of Damage/Abuse 20

TABLE OF CONTENTS

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INTRODUCTION

Brasseler GEM10, GEM15, and GEM20 sensors are digital x-ray sensors that are designed specically

for intraoral x-ray imaging upon human patients for diagnostic use. Intraoral x-rays are captured

using standard intraoral x-ray imaging techniques as performed by trained dentists and associated

care providers.

No physical, mechanical, or electrical connection exists between the Brasseler GEM sensors and the

x-ray source. The sensor is initialized via software to wait for and detect onset of exposure from the

x-ray source; and creates a digital image after being exposed with x-rays; and delivers the sensor

data to the PC that the sensor is coupled to via USB connection.

No modication of any kind is allowed to the Brasseler GEM Digital Sensor System.Any repair

must be performed exclusively by Brasseler or a Brasseler authorized vendor.

Essential Performance

The essential performance of the Brasseler GEM Sensor System is the sensor’s integration with

an imaging software (PACS) and the sensor’s ability to capture intraoral x-ray images that allow

visual recognition of dental anatomical structures and pathologies as well as abnormal dental

conditions. The digital x-ray images are used for diagnosis, treatment, and monitoring of the

dental structures, pathologies, and conditions in child and adult dental patients.

Product Description

The Brasseler GEM Digital Sensor System is an indirect converting x-ray detector. A scintillating

material converts the incident x-ray ux into visible light photons, this light is coupled optically

and directed to a CMOS technology light detection imager via a ber optic faceplate, and then

converted to digital data.

Once the sensor is initialized via software command; the design of the sensor assembly supports

automatic detection of the onset of incoming x-rays ux and which then the sensor integrates

and generates the intraoral digital x-ray image.

Brasseler GEM Digital Sensor System implements a dedicated and encapsulated electronic

assembly including a housing, an image sensor, a permanently attached USB cable, and a

software driver. The data is delivered via the USB cable connection to the PC.The power for the

electronic assembly is supplied via USB connection.

Indications for Use

Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental

radiographic images. Brasseler GEM must be operated by healthcare professionals who have been

trained and are competent using various methods of acquiring radiographic images of dental

anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with

aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned

by hand with assistance of patient.

Take precautions to protect yourself from radiation. Please refer to Instructions for Use of

the intraoral x-ray equipment being used with the Brasseler GEM Digital Sensor System.

Under no circumstances should operator of system hold sensor by hand during x-ray exposure.

Instruct patient not to bite on a sensor. Use positioning techniques to minimize ability for

patient to bite sensor. Biting a sensor may damage the internal components, affecting

image quality and performance, and resulting damage may void the Brasseler GEM Digital

Sensor System warranty.

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Intended Use: Brasseler GEM is intended for any dental practice that uses x-ray equipment for

intraoral diagnostic purposes. Brasseler GEM can be used by trained dental professionals for

patients receiving intraoral x-ray examinations and produces digital images for patients receiving

intraoral x-ray examinations for diagnostic purposes. When Brasseler GEM is to be used in a

dental practice, an optional software will be necessary. Brasseler GEM is a USB-driven digital

intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM

must be operated by healthcare professionals who have been trained and are competent using

various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be

used with dental positioning devices and holders to assist with aligning an x-ray source beam

with the sensor and anatomy.

There are no known contraindications.

Device Overview

A sensor is rst connected to a PC running Windows operating system through the standard

Universal Serial Bus (USB) port. The sensor is then positioned in the patient’s mouth by a

trained dental professional. There is no physical or electrical connection between the GEM and

the x-ray source, however once sensor is armed via software command the sensor will detect

and convert incident x-rays into a digital image, as long as the x-ray source exposing the sensor

to a minimum detectable dose.

Digital x-ray images are displayed on the computer monitor within seconds after exposing the

sensor. Images can be optimized per a user’s requirements via accompanying imaging software

and are stored as image les in the users imaging software (PACS) database.

SENSOR CONNECTED TO USB CABLE INTERNAL COMPONENTS VIEW

Proficiency with the Brasseler GEM Digital Sensor System

It is critical that all operators of a Brasseler GEM Digital Sensor System read and understand

this user guide and become familiar with the Brasseler GEM Digital Sensor System prior to using

on patients. Practicing the techniques for intraoral imaging prior to use on patients is strongly

recommended.

For new users of intraoral imaging or digital x-ray imaging and software, training is highly recom-

mended.This manual is not intended to serve as a training substitute or as a continuing education

course for intraoral imaging. Reading this manual thoroughly and then carefully practicing with

the equipment will prepare users for intraoral imaging on a patient, but these activities must be

paired with additional intraoral imaging training and/or experience.

Computer skills and an basic understanding of the Windows operating system, along with an

understanding of the imaging software (PACS) being utilized are assumed in this user manual. If

a user does not have any of the above skills a computer training course or other aides are very

highly recommended and may be necessary to avoid issues.

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Conventions Used in the Manual

The following conventions are used to bring the operator’s attention to important information:

WARNING

Alerts the operator that failure to follow the procedure could cause bodily injury

or death.

CAUTION

Alerts the operator that failure to follow the procedure could cause damage to the

equipment or cause loss of data.

X-RAY

Alerts the operator that this section references the external radiation source and

damage to the operator that may result from improper use.

IMPORTANT: Provides advice for the operator regarding use of the device or a process.

PLEASE NOTE: Highlights important or unusual points.

INSTALLATION, CARE, AND MAINTENANCE

Many errors originate from inadequate attention to hardware installation. Poor care of the Brasseler GEM

Digital Sensor System can result in damage to, or destruction of, the fragile electronic components.

Poor attention to sensor, PC, or imaging equipment maintenance procedures including adjustment

of the x-ray source, can lead to unacceptable image quality.

PLEASE NOTE: Please call Brasseler GEM Technical Support at 1-877-958-1625.

Installation should be carried out by a trained and qualied computer specialist or network technician.

Brasseler GEM Digital Sensor System units are highly sophisticated equipment that must be handled

with care and maintained in accordance with the manufacturer’s recommendations.

When calling technical support, please ensure that you have access to the computer which

is commonly used with a sensor.

Failure to maintain cybersecurity can result in compromised device functionality, loss of data,

or exposure of other connected devices or networks to security threats.

Description of Product Symbols

Please refer to “Product Symbols” in Appendix C of this document.

Hardware Requirements

IMPORTANT: For regulatory reasons, all IT components used in connection with Brasseler GEM

Digital Sensor System need to be in compliance with applicable safety standards.

Refer to Appendix B, “Conformance to Standards.”

Current hardware system requirements are available on the Brasseler website. Technology and

system requirements may change. Please consult your IT professional or Brasseler prior to the

purchase of new hardware to make sure that it will be compatible with your Brasseler GEM

Digital Sensor System.

Systems meeting but not exceeding the minimum requirements may fail to deliver a satisfactory

experience for some users or in some installations. Systems with faster processors, more memory,

bigger hard drives, and high-quality monitors will signicantly enhance performance.

It is highly recommended to always back-up all data prior to any changes and use a

certied computer professional to make any system and/or network changes. Always

back-up data and store it off-site. Before assuming that your back-up efforts have been

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successful, make sure that you understand the back-up process and practice the restore

process at least once on a test system. Verify that both the operating system and data

have been accurately preserved. Consult with your IT support team for questions.

Installing the Brasseler GEM Digital Sensor System

PLEASE NOTE: Brasseler GEM Digital Sensor Systems do not require calibration. Any calibration

les are pre-loaded in a sensor’s physical on-board non-volatile memory and

therefore the installer does not need to install calibration les onto each PC, and

which is often the case with other brands of sensors.

Installation includes:

1. Installing the device driver if it is not already available on that computer.

2. Connecting the sensor to a computer.

Installing Device Driver for Sensor

1. Ensure that the computer to which you are connecting the sensor to has a compatible imaging

software installed.

2. If the compatible imaging software doesn’t install the GEM sensor device driver it can be

downloaded from BrasselerUSADental.com/GEMSoftware. After downloading, run the installer

[GEMDriverSetlup.exe] and follow the instructions that appear on the screen.

PLEASE NOTE: For additional installation guidance and resources, visit

http://BrasselerUSADental.com/GEMSoftware

Connect a GEM Sensor

1. Carefully plug the USB end of the GEM sensor cable into the computer’s USB port. Do not use

force. Ensure that the plug is properly oriented with the USB port. Try rotating the USB plug if

it does not easily insert into the USB port.

2. When the sensor is plugged into the computer the Windows operating system will detect that

a USB device has been plugged in.

3. Follow the installation instructions that appear on the screen

4. After use is complete, unplug the USB end of the sensor cable from the USB port to disconnect

the GEM sensor.

Adjusting the X-Ray Source

Brasseler GEM Digital Sensor System are generally compatible with any dental intraoral x-ray

unit. Digital sensors normally require much shorter exposure times than lm does thanks to the

high sensitivity of the sensor technology. For this, Direct Current (DC), or high frequency x-ray

generators are recommended for optimal use. These generators provide stabilized tube voltage

(kV) and reproducible exposure doses even with the very short exposure times. Please refer to

your x-ray generator manual for the recommended exposures times for digital sensors as x-ray

exposure values vary by make and model.

IMPORTANT: X-ray generators, even among the same brands, may differ greatly in their performance

based on generator values, age, use rate, and many other factors. In addition, on

newer x-ray machines, the “digital” setting on the x-ray interface may not be the

ideal setting. Users should determine the best settings per x-ray head based on

desired image results.

Conformance to Standards

All x-ray equipment for the dental intraoral radiography used with Brasseler GEM Digital Sensor

System must conform to IEC 60601-2-65.

Brasseler GEM Sensor Systems conform to the safety standard IEC 60601-1.

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All IT components electrically connected to the Brasseler GEM Sensor System must conform

to IEC 60950-1.

Normally, the IT components are placed outside the patient environment. IT components

placed inside the patient environment, due to customer site requirements, must also conform

to IEC 60601-1.

IEC 60601-1 denes the “patient environment” as “any volume in which intentional or un-

intentional contact can occur between a Patient and parts of the Medical Equipment (ME)

or ME System or between a Patient and other persons touching parts of the ME Equipment

or ME System.”

US Federal law restricts this device to sale by or on the order of a dentist or other

licensed practitioner.

Safety Considerations

All external surfaces of the sensor, sensor cable, sensor holders, and the sensor sheaths are

considered to be Type BF applied parts and are safe for normal or accidental patient contact

during use.

Brasseler GEM Digital Sensor System do not have serviceable parts. Do not open the device

to service it. All aspects of the sensor that are meant to be attended to by the operator are

accessible without opening the internal components of the device. If there is a service problem,

contact a qualied service representative from whom you purchased your Brasseler GEM Digital

Sensor System

X-Ray Protection

The rules of dental radiography still apply to digital x-ray systems. Please continue to use

protection for your patients. As a clinician, clear the immediate area when exposing the sensor.

Mains Isolation

Disconnection from the supply mains occurs at the input to the computer. The sensor can

also be disconnected from the computer.

Prevention of Cross-Contamination

To help prevent cross-contamination between patients, place a new hygienic barrier

on the GEM sensor for each new patient. The hygienic barrier must cover the sensor

and at least 3 to 4 inches (7 to 10 centimeters) of the cable.

For information about cleaning the sensor, please refer to the Care Instructions in Appendix D.

Sensor Inspection

Always inspect the sensor, cable, and position devices for physical damage prior to every

use. See Care Instructions in Appendix D for more information.

Remove sensor from service if damage to the cable or housing is observed, other-

wise exposure to elevated surface temperature or improper functionality may result.

Disposal

Waste of electrical and electronic equipment must not be disposed as unsorted

municipal waste. It must be collected separately and must be disposed as per local

regulations. Contact your authorized representative for information concerning the

decommissioning of your equipment.

X-Ray Generator Settings

The radiation of x-ray tubes is controlled by the settings of:

• Exposure time (milliseconds) or pulses

• Voltage (kV or KVp)

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• Current (mA)

• Distance between the x-ray generator and the sensor

Some controls allow for the modication of all the above, others have xed settings for current

and voltage. Follow the instructions of the x-ray source/generator to set the desired dose values.

There is a correlation between the distance of the cone to the sensor and the dose received by

the GEM unit. The radiation that reaches the sensor decreases with the square of the distance.

If you double the distance, the sensor receives only ¼ of the radiation.

Proper Care of the Brasseler GEM Digital Sensor System

Prior to taking x-rays, each staff member should be fully trained and have a complete under-

standing of how to care for a sensor. Not adhering to the following rules to protect the sensors

may potentially result in malfunction or permanent damage.

• Store the sensor in a safe place when not in use

• Do not allow the patient to bite down on the sensor or sensor cable

• Do not roll over the cable with any wheeled items such as carts or stools

• Do not allow the sensor cable to be pinched in a drawer, door, or cabinet

• Do not twist, coil, or wrap the sensor cable tightly around any object

• Do not insert foreign objects into the sensor or cable connector

• Do not drop the sensor

• Do not clamp the sensor with devices that exert excessive force (for example: hemostats

or clamps of any type)

• Do not autoclave the sensor

• Disinfect the sensor and cable in accordance with the CDC and/or other responsible

regulatory parties including standards such as OSAP for infection control

• Use a new sheath for every patient

Do not autoclave the sensor. Autoclaving a sensor will cause permanent damage.

The sheath must be removed after each patient. The sensor must be cleaned and

disinfected after each patient use by following the Cleaning Agent guidelines. Do not

use any cleaning agents not contained within the approved list of cleaning agents.

Abuse or misuse of the sensor components may result in voiding the manufacturer war-

ranty. The manufacturer warranty does not cover visible damage to any of the Brasseler

GEM Digital Sensor System components.

See Care Instructions in Appendix D for more information.

Image Quality Assurance

Image quality depends on several factors, such as, but not limited to, the following:

• The quality of the x-ray source (kV, mA, focal spot size, distance to sensor, etc.)

• The alignment of the x-ray source to the anatomical region

• The applied x-ray dose (exposure time)

• The patient not moving during exposure

• The settings of the computer monitor

It is recommended that an operator establishes a procedure for periodic review of the image

quality. If image quality is not satisfactory, or degrading, please check the contributing system

parts and speak with a certied dental x-ray technician or Brasseler GEM Technical Support.

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APPENDIX A - EMC INFORMATION

The Brasseler GEM Digital Sensor System, like any electronic device, is subject to electromagnetic

interactions with other electronic devices. Care must be taken when operating this equipment around

other electrical equipment to avoid reciprocal interference. Potential electromagnetic or other inter-

ference could occur to this or to the other equipment. Try to minimize this interference by not using

other equipment in conjunction with this device.

The EMC information in this chapter is provided for the medical system established by connecting

the GEM unit to a computer. This computer must be compliant with IEC 60950-1 (if located outside

the patient environment) or IEC 60601-1 (if located inside the patient environment). Please consult

the documentation of the computer for completing the EMC information.

This Medical Equipment is deigned to comply with IEC 60601-1-2: 2014.This equipment generates,

uses, and can radiate radio frequency energy and, if not installed and used in accordance with the

user instructions, may cause harmful interference to other devices in the vicinity. However, there is

no guarantee that interference will not occur in a particular installation. Harmful interference to other

devices can be determined by turning this equipment on and off.Try to correct the interference using

one or more of the following:

• Reorient or relocate the receiving device

• Increase the separation between the equipment

• Consult your authorized dealer for help

The Brasseler GEM Digital Sensor System is suitable for use in hospitals except for near active HF

surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging,

where the intensity of the EM disturbance is high.

IMPORTANT: Portable/mobile radio frequency communications equipment can affect the function

of the GEM unit as well as any other electronic medical equipment. This affect may result in image

failure or image quality degradation.

Brasseler GEM Sensor Systems are USB compliant devices and shall be used with USB compliant

cables suitable for high speed/USB 2.0 cables. Such cables are either marked “USB 2.0” or “USB

High Speed.” USB certied hubs can be used to extend the distance to the USB host/computer. The

length of the cable connection to the hub or between hubs shall not exceed 5 meters.

Use of accessories, transducers, and cables other than those specied or provided by the

manufacturer of the equipment could result in increased electromagnetic emissions or

decreased electromagnetic immunity of this equipment and result in improper operation.

Using non-USB compliant cables or hubs, or exceeding the maximum count of USB hub devices

for extending the distance, can degrade the immunity of the GEM unit to electromagnetic

elds or increase the emission of electromagnetic elds from the GEM unit.

For cable extensions, use a USB Cable Extender (3 feet) or an Active USB Extender Cable (15 feet).

Use of this equipment adjacent to or stacked with other equipment should be avoided because

it could result in improper operation. If such use is necessary, this equipment and the other

equipment should be observed to verify that they are operating normally.

Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be used no closer than 30 cm (12 inches) to any part of the

Brasseler GEM Sensor Systems, including cables specied by the manufacturer. Otherwise,

degradation of the performance of this equipment could result.

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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Brasseler GEM Digital Sensor System, used with a compliant computer, is intended for use

in the electromagnetic environment specied below. The customer or the user of the Brasseler

GEM Sensor System should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions

CISPR 11

Group 1

The sensor uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely

to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B

The sensor is suitable for use in all establishments including

domestic establishments 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

Class A (*)

Voltage uctuations/icker

emissions IEC 61000-3-3

Complies (*)

(*) Computer used with the Brasseler GEM Sensor system must meet this rating.

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