applicable laws and recommendations concerning electrical safety in
Computer, and provided cables comprise a Medical
System installation shall be in accordance with the requirements of
General Information
Indications for Use
VetPro® VDX is intended to be used by veterinarians and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Contraindications
None known.
Warnings/Precautions
Radiation
Safety
Electrical
Safety
• Only qualified and authorized personnel may operate this equipment ob-
serving all laws and regulations concerning radiation protection.
• The operator at all times must remain at a safe distance from the focal
spot and the X-ray beam for operator protection.
• Full use must be made of all radiation safety features on the X-ray equip-
ment.
• Full use must be made of all radiation protection devices, accessories and
procedures available to protect the patient and operator from X-ray radiation.
• The VetPro
®
VDX sensor cable should be handled with care. Do not sharply bend or crimp the sensor cable. Doing so could permanently damage
the sensor.
• This equipment must only be used in rooms or areas that comply with all
rooms used for medical purposes, e.g., IEC, US National Electrical code,
or VDE standards.
• Before cleaning or disinfecting, this equipment must always be discon-
nected from the electrical supply.
• The computer and any other associated equipment (like USB hub) shall be
placed outside the patient’s environment (i.e.: more than 1.5 meters away
from the table). The operator shall not access the patient and such devices
at the same time.
• The computer and any other associated equipment shall be compliant with
IEC 60950 or IEC 60601.
Patient
Safety
• Prior to use always cover the sensor with a disposable hygienic protective
cover. A new cover must be used for each patient. It is recommended to
disinfect the sensor between uses.
• The VetPro
Electrical System. The Computer is not intended to be located in the pa-
®
VDX,
tient environment (within a 1.5 m radius of the patient).
•
IEC 60601-1, the Standard for Safety Requirements of Medical Electrical
CMOS sensor connects directly to a USB connection in a PC without the
, emits a luminous radiation. This light is then transferred to the photo
Product Description
VetPro® VDX is a digital imaging system for dental radiographic application.
The product is to be used for routine dental radiographic examinations such
as bitewings, periapicals, etc.
are utilized to image different anatomy and for different patient sizes. The
need for an intermediate electrical interface. VetPro® VDX works with a standard dental intraoral x-ray source without any connection to the x-ray source.
VetPro
x-ray and after the x-ray is complete, transfers the image to an imaging software program on the PC. Disposable sheaths are used with each use to prevent cross-contamination between patients. VetPro
the art intraoral x-ray detector intended for digital imaging of teeth and the
oral cavity. The system provides:
The components of the VetPro
ternal USB Cables and, the Sensor Calibration Files.
®
VDX captures an image automatically upon sensing the production of
®
VDX Sensor is a state of
• Immediate production of an image
• Digital image storage and management
• Efficient archiving and recall of images
• Elimination of film processing
®
VDX sensor system are the Digital Sensor in-
Digital Sensor
The digital sensor is designed to transform a two dimensional X-ray picture
into an electrical signal. The structure of the sensor is assembled with a first
layer of phosphor material (scintillator) which, when exposed by incident Xrays
sensitive elements of the Sensor where it is transformed to electrical potential.
The electrical signal is sent to the computer for processing.
®
Sensor
Calibration
Files
Progeny
Imaging
NOTE
During installation of the VetPro
sor serial number are stored on each computer where the sensor will be used.
For more details, refer to the VetPro
Provides the user interface to acquire, store, retrieve, transmit, review and
post process images acquired by the VetPro
details refer to the VetPro
eny Imaging User Manual.
®
The VetPro
VDX digital sensor is sensitive to intense UV light. Therefore, the
®
VDX Installation section of this manual or the Prog-
VDX sensor system, files specific to the sen-
®
VDX Installation section of this manual.
®
VDX sensor system. For more
sensor should be stored in the box provided and never exposed to direct sunlight for extensive periods of time.
The VetPro® VDX is suitable for use in all establishments, including domestic establish-
Not Applicable
Not Applicable
Compliance with Applicable Standards
The following regulatory documents apply:
General
Safety
IEC 60601-1:1995
Protection against electrical shock – Class II
Degree of protection against electrical shock – Type BF Applied Part
Degree of protection against ingress of water – IP67
Not suitable for use in the presence of flammable anesthetic mixture with air
or with oxygen or nitrous oxide.
EMI/EMC
Degree of
Protection
Imaging
Performance
IEC 60601-1-2:2007
IEC 60529: 2001
Degree of protection against ingress of water – IP67
IEC 61223-3-4:200
Line pair resolution – better than 8 lp/mm
Low contrast resolution – all holes visible
EMC
Statement
Information regarding potential EMC interference and advice for avoidance
• The VetPro
While using VetPro
®
VDX sensor is considered as non-life-supporting equipment.
®
VDX sensors adjacent to other equipment, configuration should be carefully adjusted to ensure that electromagnetic interference (EMI) does not degrade performance. Specifically, mobile RF communications equipment can effect medical electrical equipment. Please refer to the EMC table below.
• Usage limitation: VetPro
IEC 60601 compliant computer. Also, any device between VetPro
®
VDX sensors shall be used with IEC 60950 or
®
VDX
sensors and the computer (USB Hub) shall be compliant with IEC 60950 or
IEC 60601. If not, this may result in degraded electromagnetic compatibili-
The VetPro® VDX is intended for use in the electromagnetic environment specified below. The customer or the user of the VetPro® VDX should
assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emission
CISPR 11
ty.
Guidance and manufacturer's declaration - electromagnetic emissions
The VetPro® VDX 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.