MIDMARK CORPORATION PROGENY CLEARVISION User And Installation Manual

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PROGENY CLEARVISION™

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USER AND INSTALLATION GUIDE

00-02-1663 REV. B

Copyright © 2011 Midmark. All rights reserved.

MIDMARK CORPORATION

675 HEATHROW DRIVE

LINCOLNSHIRE, IL 60069, U.S.A.

PHONE [phone]

TOLL FREE [phone] (U.S. ONLY )

FAX: [phone]

WWW.PROGENYDENTAL.COM

Progeny ClearVision™: 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 ......................................................................................................... 12

Operating the Progeny ClearVision™ Sensor ........................................................................... 19

Acquiring Images ................................................................................................................ 19

Using the Sensor Sheaths .................................................................................................. 20

Using a Sensor Positioning Device ..................................................................................... 20

Recommended Maintenance .............................................................................................. 20

Cleaning and Disinfecting ................................................................................................... 20

Specifications ........................................................................................................................... 22

X-Ray Sensor ..................................................................................................................... 22

Environmental ..................................................................................................................... 22

Ter m s ....................................................................................................................................... 23

Warranty ................................................................................................................................... 23

00-02-1663 © 2011 Midmark • 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone [phone]

Progeny ClearVision™: User and Installation Guide

applicable laws and recommendations concerning electrical safety in

Computer, and provided cables comprise a

System installation shall be in accordance with the requirements of

General Information

Indications for Use

Progeny ClearVision™ is intended to be used by dentists and other qualified professionals for
producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Contraindications

None known.

Warnings/Precautions

Radiation
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.

Electrical
Safety

Patient
Safety

• The Progeny ClearVision™ 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 chair). 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.

• 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 Progeny ClearVision™,

Medical Electrical System. The Computer is not intended to be located in
the patient environment (within a 1.5 m radius of the patient).

•

IEC 60601-1, the Standard for Safety Requirements of Medical Electrical
Systems

00-02-1663 © 2011 Midmark • 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone [phone]

Progeny ClearVision™: User and Installation Guide

Two different sized sensors (size 1

captures an image automatically upon

, emits a luminous radiation. This light is then transferred to the photo

Product Description

Progeny ClearVision™ is a digital imaging system for dental radiographic ap-

plication. The product is to be used for routine dental radiographic examina­tions such as bitewings, periapicals, etc.
and size 2) are utilized to image different anatomy and for different patient siz­es. The CMOS sensor connects directly to a USB connection in a PC without
the need for an intermediate electrical interface. Progeny ClearVision™ works
with a standard dental intraoral x-ray source without any connection to the x­ray source. Progeny ClearVision™
sensing the production of 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. Proge­ny ClearVision™ Sensor is a state of the art intraoral x-ray detector 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 Progeny ClearVision™ sensor system are the Digital
Sensor internal USB Cables and, the Sensor Calibration Files.

Digital Sensor

Sensor
Calibration
Files

Software

NOTE

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.

During installation of the Progeny ClearVision™ 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 Progeny ClearVision™ Installation
section of this manual.

Provides the user interface to acquire, store, retrieve, transmit, review and
post process images acquired by the Progeny ClearVision™ sensor system.
For more details refer to the Progeny ClearVision™ Installation section of this
manual or the specific software user guide.

The Progeny ClearVision™ digital sensor is sensitive to intense UV light.
Therefore, the sensor should be stored in the box provided and never ex­posed to direct sunlight for extensive periods of time.

00-02-1663 © 2011 Midmark • 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone [phone]

Progeny ClearVision™: User and Installation Guide

Explanation of Symbols on Technical Labels

Caution, consult accompanying documents

Refer to operating instructions

Class II equipment – provides double Isolation to protect against electric
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)

00-02-1663 © 2011 Midmark • 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone [phone]

Progeny ClearVision™: User and Installation Guide

mobile RF communications equipment can effect medical electrical

e used with

sensors and the computer (USB Hub) shall be

Group 1
Class B

Not Applicable

Not Applicable

Compliance with Applicable Standards

The following regulatory documents apply:

General
Safety

EMI/EMC

Degree of
Protection

Imaging
Performance

EMC
Statement

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.

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

Information regarding potential EMC interference and advice for avoidance

• The Progeny ClearVision™ sensor is considered as non-life-supporting

equipment. While using Progeny ClearVision™ sensors adjacent to other
equipment, configuration should be carefully adjusted to ensure that elec­tromagnetic interference (EMI) does not degrade performance. Specifically,

equipment. Please refer to the EMC table below.

• Usage limitation: Progeny ClearVision™ sensors shall b

IEC 60950 or IEC 60601 compliant computer. Also, any device between
Progeny ClearVision™
compliant with IEC 60950 or IEC 60601. If not, this may result in degraded

The Progeny ClearVision™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Progeny
ClearVision™ should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

RF emission

CISPR 11

RF emission

CISPR 11

Harmonic emission

IEC 61000-3-2

Voltage fluctuations/
flicker emissions

IEC 61000-3-3

electromagnetic compatibility.

Guidance and manufacturer's declaration - electromagnetic emissions

The Progeny ClearVision™ 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.
The Progeny ClearVision™ is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.

00-02-1663 © 2011 Midmark • 675 Heathrow Drive, Lincolnshire, IL 60069, U.S.A. • Phone [phone]