Midmark DX 600 User Manual
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VISION DX
600 Series
Digital Sensor System
User Guide
0120
REF.KIT #30-A2160
REV. G
00-02-1594
Revision G01
Februar
2019
Vision DX 600 Series
Digital Sensor System
User Guide
Midmark Corporation
1001 Asbury Drive
Buffalo Grove, IL 60089, U.S.A.
Phone +1 (847) 415-9800
Toll Free +1 (888) 924-3800
Fax: +1 (847) 415-9810
www.progenydental.com
Copyright © 2019 Progeny. All rights reserved.
Vision DX 600 Series: User 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 ............................................................................... 5
Installation Configurations ............................................................................................................. 6
Compliance with Applicable Standards ......................................................................................... 7
Obtaining Technical Support ......................................................................................................... 7
EC Declaration of Conformity ........................................................................................................ 8
Authorized Representatives .......................................................................................................... 9
Operating the VisionDX USB ............................................................................................................ 10
Acquiring Images ......................................................................................................................... 10
Using the Sensor Sheaths (PN 500-430/500-431) ..................................................................... 10
Using a Sensor Positioning System ............................................................................................ 1 1
Recommended Maintenance ...................................................................................................... 1 1
Cleaning and Disinfecting ............................................................................................................ 12
Specifications .................................................................................................................................... 13
X-Ray Sensor .............................................................................................................................. 13
Control Module ............................................................................................................................ 13
Environmental .............................................................................................................................. 13
Terms ................................................................................................................................................ 14
Accessories and Part Numbers ........................................................................................................ 15
Warranty and Service ........................................................................................................................ 18
3
Vision DX 600 Series: User Guide
General Information
Indications for Use
Vision DX is intended to be used as an intraoral receiver of X-Rays for dental radiography.
Contraindications
None known.
Warnings/Precautions
Radiation
Safety
Electrical
Safety
Only qualified and authorized personnel may operate this equipment observing all laws
and regulations concerning radiation protection.
The operator at all times must remain at least 2 m (6 ft.) 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 equipment.
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 Vision DX sensor cable should be handled with care. Do not kink or crimp the sensor
cable. Doing so could permanently damage the sensor.
Only qualified and authorized service personnel should remove covers on the equipment.
This equipment must only be used in rooms or areas that comply with all applicable laws
and recommendations concerning electrical safety in rooms used for medical purposes,
e.g., IEC, US National Electrical code, or VDE standards.
Before cleaning or disinfecting, this equipment must always be disconnected from the
main electrical supply.
The Vision DX Intraoral Dental X-Ray Sensor is ordinary type medical equipment without
protection against ingress of liquids. To protect against short-circuit and corrosion, no
water or any other liquid should be allowed to leak inside the equipment.
Patient
Safety
Prior to use always cover the sensor with a disposable hygienic protective cover. A new
cover must be used for each patient.
The Vision DX, USB Module, Computer, and provided cables comprise a Medical
Electrical System. The Computer and USB Module are not intended to be located in the
patient environment (within a 1.5 m radius of the patient).
System installation shall be in accordance with the requirements of IEC 60601-1, the
Standard for Safety Requirements of Medical Electrical Systems
Patients should only be connected to applied parts of equipment complying with
IEC 60601-1. The computer and USB Module used for connection to the VisionDX USB
shall comply with the standard for Information Technology Equipment, IEC 60950-1.
4
Vision DX 600 Series: User Guide
Product Description
Progeny Vision DX Sensor is a state of the art intraoral system intended for digital imaging
of teeth and the oral cavity. The system provides:
Immediate production of an image
Digital image storage and management
Efficient archiving and recall of images
Reduction of the X-Ray dose to patient
Elimination of film processing
The components of the Vision DX Sensor system are the Digital Sensor, the USB Module,
the USB Cable, and the Sensor Calibration Files disk. An optional component is the USB
Dual-Host Switch.
Digital Sensor
USB Module
USB Cable
Sensor Calibration
Files Disk
Software
USB Dual-Host
Switch
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 X-Rays, emits a luminous radiation.
This light is then transferred to the photo sensitive elements of the Sensor where it is
transformed to electrical potential. The electrical signal is sent to the USB Module for
processing.
The USB Module processes the image and sends it as a digital signal to the software.
Connects the USB Module (standalone configuration) or the Bus-powered USB Hub
(Preva Plus integrated configuration) and the computer’s USB 2.0 port. The total cable
length may not exceed 5 m (15 ft).
During installation of the Vision DX Sensor System, files specific to the sensor serial
number are stored on each computer where the sensor will be used. For more details,
refer to the Vision DX 600 Series Installation Guide.
Provides the user interface to acquire, store, retrieve, transmit, review and post process
images acquired by the Vision DX Sensor system. For more details refer to the Vision DX
600 Series Installation Guide or the specific software user guide.
The USB Dual-Host Switch is an option that allows two separate computers to connect to
one Vision DX Sensor when the sensor is installed in the Preva Plus integrated
configuration.
Explanation of Symbols on Technical Labels
Type BF: Protection against electric shock (IEC 60601-1)
Class II: Double Isolation to protect against electric shock (I
5
54H
EC 60601-1)
Vision DX 600 Series: User Guide
Consult written instructions in User’s Manual.
Installation Configurations
The Vision DX Sensor can be installed with the Preva Plus Dental Intraoral X-Ray
System or it can be used as a standalone sensor. These configurations are shown
in Figures 1 and 2. With the addition of the optional USB Dual-Host Switch, the
Vision DX Sensor integrated with the Preva Plus can be shared by two computers.
This setup, shown in Figure 3, might be desired when the Preva Plus is mounted
in a pass-through cabinet between two operatories.
Figure 1:
Vision DX Sensor
Integrated with
Preva Plus
Figure 2:
Vision DX Sensor
Standalone
Figure 3:
Vision DX Sensor
Integrated with
Preva Plus with
Optional Dual-Host
USB Switch
6
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