Gendex GXS-700 User manual

GXS-700.book Page 6 Monday, August 1, 2011 11:25 AM
Digital Intraoral Sensors
User Manual
Manuel d'utilisateur
Manuale d'uso
Benutzerhandbuch
Manual del usuario
Gebruikershandleiding

GXS-700.book Page 6 Monday, August 1, 2011 11:25 AM

GXS-700.book Page 6 Monday, August 1, 2011 11:25 AM
User Manual

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English -iii
Chapter 1 - Introduction
Essential Performance ....................................................................................1-1
Intended Use of the Device .............................................................................1-1
Product Description ........................................................................................1-2
Proficiency with the GXS-700 .........................................................................1-2
Conventions Used in the Manual .................................................................... 1-3
Unpacking the GXS-700 System Components .................................................1-3
Contents of each Package Tier ...............................................................................1-4
System Components .......................................................................................1-5
Digital Intraoral Sensor .........................................................................................1-5
USB Connector ......................................................................................................1-5
GXS-700 Intraoral Positioning Devices ..................................................................1-6
Disposable Sanitary Sheaths .................................................................................1-7
Cables ...................................................................................................................1-7
Sensor Cradle ........................................................................................................1-8
Software CD-ROMs ................................................................................................1-8
Documentation ......................................................................................................1-8
Chapter 2 - Safety and Disposal Procedures
Sensor Inspection .......................................................................................... 2-1
Electrical Safety ..............................................................................................2-2
Mains Isolation ......................................................................................................2-2
X-ray Protection ..............................................................................................2-2
Prevention of Cross-Contamination .................................................................2-2
Product Disposal ............................................................................................2-3
Prevention of Environmental Contamination ...................................................2-3
Chapter 3 - System Configuration
Personal Computer Requirements ...................................................................3-1
Chapter 4 - Installation
Installation of Software Driver ........................................................................4-1
Mounting the Sensor Cradle ...........................................................................4-2
Table of Contents
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Chapter 5 - GxPicture Software
Status Icon ..................................................................................................... 5-1
GxPicture Options ..........................................................................................5-2
Status Icon ............................................................................................................5-2
Information ...........................................................................................................5-2
Multiple GXS-700 Sensors .............................................................................. 5-3
Image Settings ......................................................................................................5-4
Service ..................................................................................................................5-5
Chapter 6 - Use
Acquisition of Radiographic Images ................................................................6-1
Portability ......................................................................................................6-4
Hygiene ..........................................................................................................6-4
Recommended Disinfecting Solutions ...................................................................6-5
Maintenance ..................................................................................................6-6
Image Quality Assurance ................................................................................6-7
X-ray Dose / Exposure Time Settings .....................................................................6-7
X-ray Sharpness / Contrast ....................................................................................6-7
Display Image ........................................................................................................6-8
Chapter 7 - Specifications and Standards
Sensor Specifications .....................................................................................7-1
Detective Quantum Efficiency (DQE) ................................................................ 7-2
Product Symbols ............................................................................................7-3
Compatibility with Radiographic Generators ................................................... 7-5
Compatibility with Software ............................................................................ 7-6
Declaration of Conformity ...............................................................................7-7
Chapter 8 - Diagnostics
System Does Not Acquire X-ray Images ........................................................... 8-1
Appendix A - Accessories
Appendix B - EMC Information
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Chapter
1Introduction
This User Manual contains original instructions by Gendex Dental Systems for safe set-up, use
and maintenance of the Gendex GXS-700. The user must be able to read and understand the
written language of the manual.
It also contains technical specifications of the system and basic information on how the system
works.
Please read this manual carefully before starting to use the device, paying particular attention
to warnings, especially safety warnings. Operators are strongly urged to comply with the
current recommendations of the International Commission on Radiological Protection and, in
the United States, the US National Council for Radiological Protection.
Essential Performance
WARNING
No modification of this equipment is allowed.
The essential performance of the Gendex GXS-700 sensor system comprises:
•The ability of the sensor to capture X-ray images suitable for recognition of
normal anatomical structures, dental pathologies, and abnormal conditions,
where inadequate images may result in misdiagnosis, subjecting the patient
to incorrect or unnecessary dental procedures that would present an
unacceptable risk to the patient;
•The ability of the sensor holder to align the sensor with the X-ray source for
imaging the desired anatomy, where inadequate alignment may result in
repeated X-ray exposures, subjecting the patient to additional ionizing
radiation that would present an unacceptable risk to the patient;
•The ability of the single use sensor sheaths must be used to isolate the
sensor from the patient, where cross-contamination would present an
unacceptable risk to the patient.
Intended Use of the Device
The GXS-700 is a USB-driven digital sensor which is intended to acquire patient
dental intraoral radiography images. The GXS-700 shall be operated by healthcare
professionals, who are educated and competent to perform the acquisition of dental
intraoral radiographs. Specific educational requirements are determined by state and/
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1-2
or national regulatory agencies. The GXS-700 can be used either in combination with
special positioning devices to facilitate positioning and alignment with the X-ray
beam, or it may also be positioned by hand with the assistance of the patient.
Product Description
An X-ray image sensor (CMOS) is positioned in the patient’s mouth just like intraoral
film. There is no electrical or physical connection between GXS-700 and the X-ray
generator. Images are automatically acquired when X-rays are present in a dose
which is perceptible to the sensor.
Digital X-ray images are quickly displayed on the screen. Images can be optimized for
viewing via imaging software, stored as image files, and printed out on a suitable
printer if desired. VixWin Platinum is one example of a dedicated software that
employs a number of utilities for optimizing viewing and printing of images.
The GXS-700 must be connected to a PC running on a Windows operating system
through the standard USB port (Universal Serial Bus). See the “System Configuration”
paragraph for details.
Proficiency with the GXS-700
Please become acquainted with your GXS-700 sensor. The sensor is your tool. Learn
to use it well and it will become an effective aid in your diagnosis, treatment and
treatment planning process. Visual impairment is permissible so long as the user can
resolve the necessary details of the accompanying documentation, user interface and
image data. Use of corrective measures such as glasses or contact lenses is
permissible. Audio impairment is permissible so long as the user can discern audio
indications emitted by other associated equipment, such as the exposure buzzer that
sounds while X-rays are being emitted, or, in the case of deafness, so long as such
audio indications are supplemented by corresponding visual indications. Use of
corrective measures such as hearing aids is permitted.
As with all new clinical tools, it is necessary to invest a certain amount of time for
practice in order to become proficient with the sensor.
We highly recommend that you register for in-office training and that you and all of
your clinical team set aside time to learn the system together. This manual is not
intended to serve as a substitute for this training. However, as preparation for the
training, we do encourage you to read the manual thoroughly and practice with your
equipment safely and carefully for at least one week prior to your training date.
Please note that this manual assumes that new users possess basic computer skills
and an understanding of the Windows® operating system. Absent this experience, we
highly recommend that you obtain these skills through a computer course, video, or
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Introduction
English 1-3
textbook. Your Gendex representative may be able to suggest (although not endorse)
one or more of these computer learning resources.
Conventions Used in the Manual
The following conventions are used to bring the operator’s attention to important information:
Unpacking the GXS-700 System Components
The GXS-700 system is carefully inspected and packaged prior to shipment. If the
GXS-700 system was shipped to you, please remove the contents of the shipping
container and be sure to identify and directly locate each of the system components
shown below.
NOTE: Report any damaged components to the shipping company and any missing
components to your dealer within 24 hours of receiving the shipment.
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.
Important: Provides advice for the operator regarding use of the device
or a process.
NOTE: Highlights important or unusual points.
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Contents of each Package Tier
Documentation and Software Tier
Sensor and Accessories Tier
Sensor Positioning System Tier
GXS-700 Sensor
Calibration File CD-ROM,
Disposable Sanitary
Sensor Cradle
USB Extender Cable
Endo
Periapical and
Bitewing Rings
Periapical, Bitewing
Holders
and Endo Bars
Anterior Holders
Bitewing Holders
Posterior Holders
Quick Reference
Guide
Sheaths,
User Manuals
Software CD-ROMS
- GxPicture
- VixWin (Optional)
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Introduction
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System Components
Digital Intraoral Sensor
The GXS-700 sensors are USB-driven digital intraoral sensors based on a CMOS
technology that has been specifically designed for dental applications. The GXS-700
sensors are available in two formats: size 1 (active area: 20x30mm) and size 2 (active
area: 26x36mm).
USB Connector
Size 2 Sensor
Size 1 Sensor
Sensor ID Label
(typical) Connector Cable Label
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GXS-700 Intraoral Positioning Devices
Specifically designed to support the sensor and align it with the X-ray beam and with
the teeth of the upper and lower jaws.
RED - BITEWING
BLUE - ANTERIOR YELLOW - POSTERIOR
GREEN - ENDODONTIC
BITEWING BAR
ENDO BAR
PERIAPICAL BAR
UNIVERSAL RING
UNIVERSAL RING
UNIVERSAL RING
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Disposable Sanitary Sheaths
Used as a barrier for the sensor. Supplied in a package of 100 pieces.
Cables
1. 1 meter (3 feet) USB extender cable.
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Sensor Cradle
Designed to provide a safe and secure storage solution for GXS-700 sensors.
Software CD-ROMs
1. GxPicture CD containing GxPicture installation files and utilities.
2. Calibration Files CD containing the sensor calibration files.
3. Optional: VixWin Platinum CD (installation and utilities) and VixWin
Platinum User Manuals (multiple languages).
Documentation
1. GXS-700 User Manual
2. GxPicture Quick Install Guide
3. Optional: VixWin Platinum User Manual
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Chapter
2Safety and Disposal
Procedures
The device must be installed and used in accordance with the safety regulations and
instructions for use supplied in this User Manual, for the purposes and applications for which
it is intended.
All external surfaces of the sensor, sensor cable, sensor holders and the sensor sheaths are
considered to be applied parts and are safe for normal or accidental patient contact during use.
The GXS-700 has no serviceable parts and does not require to be calibrated. Do not open the
device to service it. All aspects of the GXS-700 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 qualified dealer service representative or Gendex Technical Support.
Important: Portable/mobile radio frequency communications equipment can affect the
function of the GXS-700 sensor as well as any other electronic medical
equipment.
GXS-700 is a USB compliant device 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 Hi-Speed.”
USB certified 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 5m.
CAUTION
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
GXS-700 sensor to electromagnetic fields or increase the emission of
electromagnetic fields from the sensor.
Sensor Inspection
Always inspect the sensor, cable, and positioning devices for physical damage prior to every
use.
WARNING
Remove sensor from service if damage to the cable or housing is
observed, otherwise exposure to elevated surface temperature or
electrical energy may result.
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Electrical Safety
The product must be used only in rooms or areas which comply with all laws and regulations
applicable to electrical safety in medical premises, such as CEI standards regarding use of an
additional ground terminal for potential connections.
The GXS-700 sensor conforms to safety standard IEC 60601-1.
Gendex GXS-700 sensor is not suitable to be operated in oxygen rich and/or explosive
environments.
All IT components electrically connected to the GXS-700 sensor 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 defines the “Patient environment” as “any volume in which intentional or
unintentional contact can occur between a Patient and parts of the ME Equipment or
ME System or between a Patient and other persons touching parts of the ME Equipment or
ME System.”
Mains Isolation
Disconnection from the supply mains occurs at the input to the computer. The
sensor can also be disconnected from the computer.
X-ray Protection
All X-ray equipment for Dental Intra-ora. Radiography for GXS-700 must conform to IEC
60601-2-65:2012.
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.
Prevention of Cross-Contamination
To help prevent cross-contamination between patients, place a new hygienic barrier
on the sensor for each new patient. The hygienic barrier must cover the sensor and
at least 3-4 in. (7-10 cm) of the cable.
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Safety and Disposal Procedures
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Product Disposal
The GXS-700 sensor contains a small amount a lead, similar to the lead foil used in
a dental intra-oral X-ray film. Please contact your dealer or supplier for further
information about product disposal at the end of the product’s lifetime.
Prevention of Environmental Contamination
Dispose of sheaths and other consumables following the normal dental office procedure for
biomedical waste. Improper disposal of biomedical waste can lead to the spread of illness of
disease.
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Chapter
3System
Configuration
Personal Computer Requirements
NOTE: Gendex GXS-700 is a USB certified device and shall be used with USB
compliant cables suitable for high speed/USB 2.0 components. Certified USB
cable extenders are available from Gendex. Certified powered USB active
hubs can also be used to extend the distance to the USB host/computer. The
total length of all cabling, including the GXS-700 shall not exceed 5m,
unless a powered USB active hub is used.
CAUTION
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
GXS-700 sensor to electromagnetic fields or increase the emission of
electromagnetic fields from the sensor.
Hard Disk
The choice of hard disk capacity depends on the number and size of images to be
stored. Intraoral images vary in size from 4.7 MB (uncompressed TIFF images with a
Size 2 sensor) to 100 KB (JPEG/JFIF with 50% compression). A 20 GB hard disk is
normally capable of satisfying the requirements of the average user. To guarantee
data security, however, it is preferable to allow for duplication to provide back-ups of
files containing diagnostic images and information.
Minimum System
Requirements
Recommended
Operating
System
Microsoft®Windows®XP with
service pack SP3
Microsoft®Windows®7 Professional
32 and 64 bit
Processor Intel Celeron®M 1.6 GHz Intel®Core™2 Duo 2.4 GHz
Memory 512 MB 2 GB
Hard Disk 40+ GB 120+ GB
Display
Setting
800 x 600 1024 x 768 at 32 bit true color
Video Memory 1+ MB 128+ MB
Ports USB 2.0 USB 2.0
Standards In compliance with the UL/IEC/
EN 60950-1 standard
In compliance with the UL/IEC/EN
60950-1 standard
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Backup
Spare copy to permit recovery of data if lost. The database of patients and images
should be copied frequently (e.g. once a week) onto a removable mass storage device
(removable hard disk, CD-ROM, Pen-drive etc.). You may use the back-up functions
offered by Microsoft®software or directly copy files of data and images onto a
removable device.
Application Software
Some diagnostic imaging software, practice management software or other third-
party software may have different minimal system requirements. Refer to the
requirements of the specific software in its User Manual.
Important: If the GXS-700 System is used with imaging software other than
VixWin Platinum, then the Intended Use of that software needs to
include dental intra-oral x-ray.
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