BRASSELER USA GEM User manual

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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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Brasseler GEM 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.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV,
+/- 15 kV air
Complies
Floors should be wood, con-
crete, or ceramic tile. If oors
are covered with synthetic
material, the relative humid-
ity should be at least 30%.
Electrical fast
transient/burst IEC
61000-4-4
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
Complies (*)
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Surge
IEC 61000-4-5
+/- 1 kV differential mode
+/- 2 common mode
Complies (*)
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0% UT; 0.5 cycle at 0o, 45o, 90o, 135o,
180o, 225o, 270o, and 315o 0% UT;
1 cycle
70% UT; 25/30 cycles for 50 Hz and 60
Hz, respectively Single phase: at 0o
0% UT; 250/300 cycle for 50 Hz and
60 Hz respectively
Single phase: at 0o
Complies (*)
Mains power quality should
be that of a typical commer-
cial or hospital environment.
If the user of the sensor re-
quires continued operation
during power mains inter-
ruptions, it is recommended
that the sensor be power
from an uninterruptible pow-
er supply or a battery.
VDI specs per 3rd edition:
<5% UT (>95% dip in UT) for 0,5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 s
Power frequency
(50/60Hz) magnetic
eld
IEC 61000-4-8
30 A/m, 50 Hz or 60 Hz Complies
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in atypical com-
mercial or hospital environ-
ment.
NOTE 1 UT is the mains voltage prior to application of the test level.
(*) Computer used with the Brasseler GEM Sensor system must meet this rating.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Brasseler GEM 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.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
Conducted RF IEC
61000-4-6
AC Mains:
3 V, 0.15 MHz – 80 MHz
6 V in ISM band between
0.15 MHz and 80 MHz 80% AM at 1 kHz
SIP/SOPS:
3 V, 0.15 MHz – 80 MHz
6 V in ISM band between
0.15 MHz and 80 MHz
80% AM at 1 kHz
Complies (*)
Portable and mobile RF
communications equipment
should be used no closer
to any part of the Brasseler
Gem sensor, including ca-
bles, than the recommended
separation distance calcu-
lated from the equation
applicable to the frequency
of the transmitter.
Recommended separation
distance:
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
V1 = 3 Vrms E1 = 3 V/m
Field strengths from xed RF
transmitters, as determined
by an electromagnetic site
surveya, should be less than
the compliance level in each
frequency range.bInterfer-
ence may occur in the vi-
cinity of equipment marked
with the following symbol:
Radiated RF IEC
61000-4-3
ed3.0 (with
A1:2007+A2:2010)
3 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz
Complies (*)
NOTE 1 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection
from structures, objects and people.
The ISM (Industrial, Scientic and Medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15
MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15
MHz, 14 MHz to 4,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7
MHz and 50,0 MHz to 54,0 MHz.
aField strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radi-
os, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the
measured eld strength in the location in which the FI-XRS systems used exceeds the applicable RF compliance level above,
the Brasseler GEM Sensor Systems should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Brasseler GEM Sensor System.
bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m
(*) Computer used with the Brasseler GEM Sensor system must meet this rating.

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Recommended separation distances between portable and mobile
RF communications equipment and the Brasseler GEM Sensor System
The Brasseler GEM Digital Sensor System is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled.The customer or the user of the sensor can
help prevent electromagnetic interference by maintaining a minimum distance between porta-
ble and mobile RF communications equipment (transmitters) and the sensor as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (Watts)
Separation distance according to frequency of transmitter (Meters)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection
from structures, objects and people.

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APPENDIX B —SPECIFICATIONS AND STANDARDS
Sensor Architecture Indirect converting dental intraoral CMOS x-ray sensor
Image Pixel Size: 19.5µm
Image Resolution: 20+ visible lp/mm
Maximum Gray Levels: 16,384 (14 bit)
X-Ray Parameters Sensor can be used with dental x-ray generators in the range of 60 to 70 kV;
at minimal 40 µGy incident dose
Electrical Rating DC 5V, 0.5W
Connection to PC USB 2.0 compliant
Cable Length 1.9m
Degree of Protection
Against Shock
Type BF
Applied part
Mode of Operation Continuous
Method of Sterilization Sensor not suitable for sterilization or autoclave
Type of Protection Against
Electrical Shock Class II
Suitability for Use in an
OXYGEN RICH
ENVIRONMENT
Not intended for use in an Oxygen Rich Environment
Protection Against Harmful
Ingress of Water
IPX8 (Protected against the effects of continuous immersion in water at 1.1
meters for up to 35 minutes)
Sensor Technology CMOS
Environmental
Conditions
Humidity Air
Pressure
Ambient
Temperature
Usage
Brasseler Gem units are not suitable
to be operated in oxygen rich and/or
explosive environments
30% to 75% 700 hPa to 1060
hPa in altitudes up
to 3000 meters
5° to 30°C
Transportation and Storage
Transport in the supplied protective
pack
10% to 95% -40° to 70°C
Packaging Labels
EU Classication Class IIa medical device according to MDD 93/42/ECC
External Dimensions (mm) Active Imaging Area (mm) Active Image Area (px)
GEM10 - Size 1 36.36 x 24.53 x 12.52 30.01 x 20.01 1539 x 1026
GEM15 - Size 1.5 38.83 x 29.63 x 13.01 32.99 x 25.82 1692 x 1324
GEM20 - Size 2 41.80 x 30.48 x 13.02 35.92 x 25.82 1842 x 1324

BrasselerUSA.com | BrasselerCanada.comEnglish | 15
APPENDIX C —PRODUCT SYMBOLS
Symbol Title of the
Symbol
Reference
Number
Standard
Containing
the Symbol
Fuction/ Description
per Standard
Manufacturer
Interpretation
Type BF
applied part
5333 IEC 60417 To identify a type BF
applied part complying
with IEC 60601-1
To identify a type BF
applied part complying
with IEC 60601-1
Direct Current 5031 IEC 60417 To indicate on the
rating plate that the
equipment is suitable
for direct current only;
to identify relevant
terminals
Direct Current
General
warning sign
W001 ISO 7010 To signify a general
warning
Warning
Radioactivity
and ionizing
radiation
W003 ISO 7010 To warn of radioactive
materials or ionizing
radiation
Radiation Warning
Caution 0434B ISO 7000 To indicate that caution
is necessary when
operating the device or
control close to where
the symbol is placed,
or to indicate that the
current situation needs
operator awareness or
operator action in order
to avoid undesirable
consequences.
Please refer to the
written instructions in
this manual
Do not reuse 1051 ISO 7000 To indicate that the
item is for single use
only and must not
be used more than
once, for example, on
packages of medical
disposables
Please contact your
supplier for further
information about the
product disposal at the
end of the product’s
lifetime
Marking of
electrical and
electronic
equipment
N/A BS EN
50419
This symbol on
the products and/
or accompanying
documents means that
the used electrical and
electronic products
should not be mixed
with general household
waste
Please contact your
supplier for further
information about the
product disposal at the
end of the product’s
lifetime
Manufacturer 3082 ISO 7000 To identify the manu-
facturer of a product.
This symbol shall be
used lled in all appli-
cations to differentiate
it from ISO 7000-2497
Manufacturer

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Date of man-
ufacture
2497 ISO 7000 To indicate the date on
which a product was
manufactured
Date of manufacture
Distributor 3724 ISO 7000 To identify the distribu-
tor of a product.
Distributor
Catalogue
number
2493 ISO 7000 To identify the man-
ufacturer’s catalogue
number, for example
on a medical device
or the corresponding
packaging.
The catalogue number
shall be placed adja-
cent to the symbol.
Catalogue number
Serial
number
2498 ISP 7000 To identify the
manufacturer’s serial
number, for example
on a medical device
or its packaging. The
serial number shall be
placed adjacent to the
symbol.
Serial number
Consult
instructions
for use or
consult
electronic
instructions
for use
1641 ISO 7000 Indicates the need for
the user to consult the
instructions for use
When the instructions
for use and patient
information are located
within the same
electronic instructions
for use, a manufacture
may choose to use
this symbol to indicate
both.
Follow the operating
instructions for use
N/A N/A N/A N/A IPX8 (Protected against
the effects of continu-
ous immersion in water
at 1.1 meters for up to
35 minutes)
Atmospheric
pressure
limitation
2621 ISO 7000 To indicate the accept-
able upper and lower
limits of atmospheric
pressure for transport
and storage
Atmospheric
pressure limitation
Humidity
limitation
2620 ISO 7000 To indicate the
acceptable upper and
lower limits of relative
humidity for transport
and storage
Humidity
limitation

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Temperature
limit
0632 ISO 7000 To indicate the max-
imum and minimum
temperature limits at
which the item shall
be stored, transported
or used
Temperature
limitation
This way up 0623 ISO 7000 To indicate correct
upright position of the
transport package
This end up
N/A N/A ISO 7000 N/A Stocking Unit
Keep away
from rain
0626 ISO 7000 To indicate that the
transport package shall
be kept away from rain
and in dry conditions
Keep Dry
Fragile,
handle with
care
0621 ISO 7000 To indicate that
the contents of the
transport package are
fragile and the package
shall be handled with
care
Fragile, handle with
care
Prescription
device
801.109 FDA Title
21
Caution: US Federal
law restricts this device
to sale by or on the
order of a physician
or other licensed
practitioner
Clinical use only

BrasselerUSA.com | BrasselerCanada.com English18 |
APPENDIX D - CARE INSTRUCTIONS
This section contains the proper handling for the GEM intraoral dental sensors. Failure to follow these
care instructions may result in voiding of the Warranty.
Handling
• Do not use force to pull the sensor out of the USB port it is plugged into. The joint between
cable and housing can withstand more the 500 pulling cycles with a pulling force of 30 N.
The USB connector for the sensor has an endurance of 5,000 insertion / pulling cycles.
• Do not drop a sensor onto, or let it knock against, a hard surface. Even without obvious
outward damage being visible, internal damage can occur.
• The sensor capsule and cable can withstand minimal biting (up to 50 N) as it may happen
during the intended usage, however biting is not recommended.
• The sensors are not suitable for sterilization. Do not autoclave.
• The operating ambient temperature shall not exceed 30°C for a sustained period of time.
However it can go to 37°C for less than 2 minutes.
Cleaning
The sensor surfaces/coatings, including the cable and all other material, are subject to hygienic
considerations (excluding the USB connector) as dened below for Cleaning and Wet Disinfection:
In the scope of this requirement, Cleaning is dened as soft wiping the sensor and/or cable
surfaces with either a soft cotton towel immersed with a disinfection liquid or a commercial
available disinfection wipe. All surfaces of the sensor / cable may come into contact with the
disinfection liquid and the disinfection “occurs” while the liquid is present / drying. This wiping
procedure is typically random in movement and intermittent; hence, the total wiping time is
stated within this requirement.
Material / Cleaner Total Wiping Time
Isopropyl Alcohol (70%) 15 seconds
CaviCide® (Manufactured by Metrex) 15 seconds
CaViWipes™ (Distributed by Metrex) 15 seconds
ProSpray C-60™ (Manufactured by Certol) 15 seconds
Sani-Cloth® Plus, HB (Manufactured by PDI) 15 seconds
• The design can withstand up to 10,000 Cleanings for all materials listed above using the
dened wiping time.
Material / Cleaner Submersion Time
Isopropyl Alcohol (70%) 15 minutes
CaviCide® (Manufactured by Metrex) 15 minutes
ProSpray C-60™ (Manufactured by Certol) 15 minutes
• The sensor can withstand a total of 1,250 Wet Disinfections for all of the materials listed
above using the dened insertion time per cycle.

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Examples of Damage / Abuse
Below are examples of typical customer damage
Acceptance Levels Acceptance Criteria Acceptance Denitions
Target condition As shipped condition, close to
perfect
Desirable condition
Acceptable condition Bite mark 1 – minor
Bite mark 2 – medium
Housing damage 1 – minor
Condition is not necessarily perfect
but maintains integrity and reliabili-
ty of the assembly
E.g. Minor scratches, minor bite
marks, minor cosmetic damage,
etc.
Reject condition Bite mark 3 – severe
Cable cut
Cable damaged
Cable kinked
Housing cracked
Housing damaged
Housing dented
A defect condition that impacts
form, t and function of the
assembly.
E.g. Heavy housing damage,
deep scratches, deep bite marks,
cracked housing, damaged USB
connector, tool markings, broken
cable strain relief, kinked cable, cut
cable, etc.

REV 0 B-5641B-09.22©2022 Brasseler USA and RealCloud Imaging. All Rights Reserved.
Brasseler U.S.A. Dental, LLC
One Brasseler Blvd
Savannah, GA 31419 U.S.A.
This user guide and product(s) described herein are protected by copyright laws and the international copyright treaties, as well
as other intellectual property laws and treaties.
Many designations used by manufacturers and sellers to distinguish their products are claimed as trademarks. Where Brasseler
USA & RealCloud Imaging was aware of a trademark claim, such designations have been printed in capital or initial capital
letters in this user guide.
The Cypress Semiconductor Corporation holds the copyright of the USB interface used in these product(s).
Language - English is the original language of this user manual.