MIDMARK CORPORATION VETPRO VDX User And Installation Manual

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00-02-1673 Rev. B (ECN P2620)
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VETPRO
IGITAL SENSOR SYSTEM
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VDX
USER AND INSTALLATION GUIDE
00-02-1673 REV. B
Copyright © 2011 Midmark. All rights reserved.
MIDMARK CORPORATION
675 HEATHROW DRIVE
LINCOLNSHIRE, IL 60069, U.S.A.
PHONE +1 (847) 415-9800
TOLL FREE (888) 924-3800 (U.S. ONLY )
FAX: +1 (847) 415-9810
WWW.PROGENYDENTAL.COM
VetPro® VDX: User and Installation Guide
TABLE OF CONTENTS
General Information ....................................................................................................................... 4
Indications for Use .................................................................................................................. 4
Contraindications .................................................................................................................... 4
Warnings/Precautions ............................................................................................................. 4
Product Description ................................................................................................................ 5
Explanation of Symbols on Technical Labels .......................................................................... 6
Compliance with Applicable Standards .................................................................................. 7
Obtaining Technical Support ................................................................................................... 9
Authorized Representatives .................................................................................................... 9
Installation ................................................................................................................................... 10
Overview ................................................................................................................................ 10
Before You Begin ................................................................................................................... 10
Installation Procedure ............................................................................................................ 11
Operating the VetPro
Acquiring Images ................................................................................................................... 18
Using the Sensor Sheaths ..................................................................................................... 19
Recommended Maintenance ................................................................................................ 19
Cleaning and Disinfecting ..................................................................................................... 19
Specifications .............................................................................................................................. 21
X-Ray Sensor ........................................................................................................................ 21
Environmental ........................................................................................................................ 21
Terms ........................................................................................................................................... 22
Warranty ...................................................................................................................................... 22
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VDX Sensor ............................................................................................. 18
00-02-1673 © 2011 Midmark 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone +1 (847) 415-9800 3
VetPro® VDX: User and Installation Guide
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
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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
00-02-1673 © 2011 Midmark 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone +1 (847) 415-9800 4
Systems
VetPro® VDX: User and Installation Guide
Two different sized sensors (size 1 and size 2)
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.
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VDX captures an image automatically upon sensing the production of
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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
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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.
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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.
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The VetPro
VDX digital sensor is sensitive to intense UV light. Therefore, the
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VDX Installation section of this manual or the Prog-
VDX sensor system, files specific to the sen-
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VDX Installation section of this manual.
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VDX sensor system. For more
sensor should be stored in the box provided and never exposed to direct sun­light for extensive periods of time.
00-02-1673 © 2011 Midmark 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone +1 (847) 415-9800 5
VetPro® VDX: User and Installation Guide
ouble Isolation to protect against electric
Explanation of Symbols on Technical Labels
Caution, consult accompanying documents
Refer to operating instructions
Class II equipment – provides d shock
Type BF – provides additional protection against electric shock
Degree of protection – IP67 means that sensor casting is :
totally protected against dust,
protected against the effect of immersion between 15 cm and 1 m.
Direct current
Serial number
Catalogue number
Date of manufacture
Place of manufacture (manufacturer)
00-02-1673 © 2011 Midmark 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone +1 (847) 415-9800 6
VetPro® VDX: User and Installation Guide
Group 1
RF emission
Class B
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
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VDX sensor is considered as non-life-supporting equipment.
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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
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VDX sensors shall be used with IEC 60950 or
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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.
CISPR 11
Harmonic emission
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
00-02-1673 © 2011 Midmark 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone +1 (847) 415-9800 7
ments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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