KaVo IXS User manual

KaVo IXS
User Manual
Manuel de l’utilisateur
Cover Front.fm Page i Monday, May 20, 2019 4:11 PM

Cover Front.fm Page ii Monday, May 20, 2019 4:11 PM

KaVo IXS
Digital Intraoral X-ray Sensor
User Manual
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English -iii
Chapter 1 - Introduction
Essential Performance ................................................................................. 1-1
Indications for Use ....................................................................................... 1-1
Product Description ...................................................................................... 1-2
Proficiency with the KaVo IXS ...................................................................... 1-2
Conventions Used in the Manual ................................................................. 1-3
Unpacking the System Components ............................................................ 1-3
Contents of Sensor Box ......................................................................................1-4
System Components .................................................................................... 1-5
Digital Intraoral Sensor ........................................................................................1-5
Device Labeling ...................................................................................................1-6
Cables .................................................................................................................1-7
Sensor Garage ....................................................................................................1-7
Documentation ....................................................................................................1-7
USB Software Kit .................................................................................................1-7
Chapter 2 - Safety and Disposal Procedures
Sensor Inspection ........................................................................................ 2-2
Electrical Safety ........................................................................................... 2-2
Mains Isolation ....................................................................................................2-2
X-ray Protection ........................................................................................... 2-3
Prevention of Cross-Contamination ............................................................. 2-3
Product Disposal .......................................................................................... 2-3
Prevention of Environmental Contamination ................................................ 2-3
Prevention Against Cybersecurity Threats ................................................... 2-3
Chapter 3 - System Configuration
Personal Computer Requirements ............................................................... 3-1
Chapter 4 - Installation
Installation Steps .......................................................................................... 4-1
Sensor Calibration Files ............................................................................... 4-2
Frequently Asked Questions for Installation ................................................. 4-3
Mounting the Sensor Garage ....................................................................... 4-4
Table of Contents
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Table of Contents
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-iv
Chapter 5 - Use
Acquisition of Radiographic Images ............................................................. 5-1
Portability ..................................................................................................... 5-2
Hygiene ........................................................................................................ 5-2
Recommended Disinfecting Solutions .................................................................5-3
Maintenance ................................................................................................. 5-3
Image Quality Assurance ............................................................................. 5-3
X-ray Dose / Exposure Time Settings .................................................................5-4
X-ray Sharpness / Contrast .................................................................................5-4
Display Image ......................................................................................................5-4
Chapter 6 - Specifications and Standards
Sensor Specifications ................................................................................... 6-1
Compatibility with Radiographic Generators ................................................ 6-2
Chapter 7 - Troubleshooting
System Does Not Acquire X-ray Images ...................................................... 7-1
Appendix A - Accessories
Appendix B - EMC Information
Appendix C - Product Symbols
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English 1-1
Chapter
1Introduction
This User Manual contains original instructions by KaVo for safe set-up, use and
maintenance of the KaVo IXS. 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 KaVo IXS 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
mis-diagnosis, 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.
•The ability of the single use sensor sheaths to isolate the sensor
from the patient, where cross-contamination could present an
unacceptable risk to the patient.
Indications for Use
The KaVo IXS is a USB-driven digital sensor which is intended to acquire dental
intraoral radiographic images. The KaVo IXS shall be operated by healthcare
professionals, who are educated and competent to perform the acquisition of
dental intraoral radiographs.
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The KaVo IXS sensor 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.
WARNING
Take the necessary steps to protect yourself from radiation. For
proper operator positioning, refer to the ‘Instructions for Use’ of your
intraoral X-ray equipment.
WARNING
Under no circumstances should the dental professional hold the
sensor by hand during the X-ray exposure.
Product Description
The KaVo IXS sensor is an indirect converting x-ray detector, e.g. incident x-
rays are converted by a scintillating material into (visible) light, this light is
coupled optically to a light detection imager based on CMOS technology.
The design of the sensor assembly supports the automatic detection of the
incident x-rays to generate digital images for dental intra oral applications.
The KaVo sensor supports USB2.0 and USB3.x connectivity to personal
computers using a dedicated electronic assembly and a sensor software driver.
Proficiency with the KaVo IXS
Please become acquainted with your KaVo IXS 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.
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Introduction
English 1-3
For new KaVo users, 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 textbook. Your KaVo 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 System Components
The KaVo IXS system is carefully inspected and packaged prior to shipment. If
the KaVo IXS 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 Sensor Box
Top Layer
KaVo
Bottom Layer
KaVo Sensor
Garage
Sensor USB
Sensor Sheaths
Extender
Cable
KaVo IXS
User Manual
IXS Sensor
Software USB
USB Cable
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Introduction
English 1-5
System Components
Digital Intraoral Sensor
The KaVo IXS sensors are USB-driven digital intraoral sensors based on a
CMOS technology that has been specifically designed for dental applications.
The KaVo IXS sensors are available in two formats: Size 1(active area:
20x30mm) and Size 2(active area: 26x36mm).
Size 1Size 2
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Device Labeling
Sensor ID Label
(typical)
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Introduction
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Cables
1. 1 meter (3 feet) USB extender cable.
Sensor Garage
Designed to provide a safe and secure storage solution for KaVo IXS sensors.
Documentation
1. KaVo IXS Sensor User Manual
2. KaVo IXS Software Update Driver
USB Software Kit
Contains update software drivers.
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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 KaVo IXS has no serviceable parts and does not require calibration. Do not
open the device to service it. All aspects of the KaVo IXS 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 KaVo Technical Support.
Important: Portable/mobile radio frequency communications equipment can affect
the function of the KaVo IXS sensor as well as any other electronic
medical equipment.
KaVo IXS 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.
NOTE: Certified Hub (1.013.3958) is available for purchase and sold
separately.
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 KaVo IXS sensor to electromagnetic fields or
increase the emission of electromagnetic fields from the sensor.
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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.
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, where provisions for
safety ground connections are present.
All X-ray equipment for Dental Intra-oral Radiography used with the KaVo IXS
sensor must conform to IEC 60601-2-65.
The KaVo IXS sensor conforms to safety standard IEC 60601-1.
The KaVo IXS sensor is not suitable to be operated in oxygen rich and/or explosive
environments.
All IT components electrically connected to the KaVo IXS 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.
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Safety and Disposal Procedures
English 2-3
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.
CAUTION
US Federal law restricts this device to sale by or on the order of a
dentist or other licensed practitioner.
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.
Product Disposal
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.
Prevention Against Cybersecurity Threats
Protecting your practice against cybersecurity threats is shared responsibility
between us as the manufacturer and you as the heath care provider. KaVo has
taken precautions to ensure that your IXS sensor, as shipped from the factory, is
protected against such threats. Additionally, during on-site repairs, your IXS sensor
is only accessible by trained KaVo Customer Support Representatives. However,
we cannot protect your network system.
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We recommend having a qualified IT security professional hired by you to check
your network system for proper protection against viruses, malware, and intrusions
(e.g. anti-virus software, and/or use of firewall).
WARNING
Failure to maintain cybersecurity can result in compromised device
functionality, loss of data (medical or personal) availability or integrity,
or exposure of other connected devices or networks to security
threats.
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English 3-1
Chapter
3System Configuration
Personal Computer Requirements
NOTE: The KaVo IXS 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 KaVo. 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 KaVo IXS
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 KaVo IXS 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 the Size 2 sensor) to 100 KB (JPEG/JFIF with 50% compression).
To guarantee data security, however, it is preferable to allow for duplication to
provide back-ups of files containing diagnostic images and information.
Example calculation: 10 patients per day x 20 images per patient x 250
workdays per year x 5 MB image= 250 GB per year.
Recommended
Operating System Microsoft Windows 10 Professional 64
Processor Core I5
Memory 8 GB
Hard Disk 512 GB
Display Setting 2560 x 1440 (QHD), 1920 x 1080 (minimum)
Video Memory 128+ MB
Ports USB 2.0 / USB 3.x
Standards In compliance with the UL/IEC/EN 60950-1 standard
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Backup
It is highly recommended to maintain a spare backup copy to permit data
recovery. The database of patients and images should be copied frequently
(e.g. once a week) onto a removable mass storage device (removable hard
drive, USB, etc.). You may use the back-up functions offered by Microsoft®
software or directly copy files of data and images onto a removable device.
Supported Imaging Software
•VixWin Platinum 3.6.1 or higher
•DEXIS 9.4.9 or higher
•DEXIS 10.1.6 or higher
•DTX Studio Clinic 1.6 or higher
•CLINIVIEW 11.5.2 or higher with KaVo Driver 19.1 or higher
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 KaVo IXS System is used with imaging software other
than those listed above, then the Intended Use of that software
needs to include dental intra-oral x-ray.
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