Progeny JB-70 Manual de usuario

JB-70 Dental X-Ray System

User Manual

00-02-1568 Rev A

Progeny Dental

1407 Barclay Boulevard

Buffalo Grove, Illinois 60089 U.S.A.

Phone: (888) 924-3800 Fax: (847) 459-5175

WWW.progenydental.com

Table of Contents JB-70 
 
i 
Table of Contents 
General Information.........................................................................................................3 
Product Description................................................................................................................ 3 
Compliance with Applicable Standards .................................................................................. 5 
Certified Components ............................................................................................................ 5 
EC Declaration of Conformity................................................................................................. 6 
Authorized Representatives................................................................................................... 7 
Safety..................................................................................................................................... 7 
Explanation of Symbols on Technical Labels ......................................................................... 8 
Obtaining Technical Support.................................................................................................. 8 
Operating the JB-70 Dental X-Ray System.....................................................................9 
Operator Panel Controls......................................................................................................... 9 
Taking an X-Ray...................................................................................................................10 
Using the 12 in Cone (30-A2033)..........................................................................................11 
Recommended Maintenance ........................................................................................12 
Regular Maintenance............................................................................................................12 
Cleaning and Disinfecting......................................................................................................12 
Checking System Functions..................................................................................................12 
System Function Checklist....................................................................................................13 
Solving Performance Issues..........................................................................................14 
Performance Issues..............................................................................................................14 
Obtaining Technical Support.................................................................................................14 
Setting Pre-programmed Exposure Times....................................................................15 
Power On Settings................................................................................................................15 
Pre-programmed Exposure Times ........................................................................................15 
Changing Programmed Exposure Times...............................................................................17 
Specifications................................................................................................................18 
JB-70 Dental X-Ray System..................................................................................................18 
 

Table of Contents JB-70

General Information JB-70

General Information

Product Description

The JB-70 Dental X-Ray System is a state-of-the-art intra-oral x-ray machine. The

JB-70 consists of five components, as shown in Figure 1 Component Diagram: the

Control Unit, the Tubehead, the Articulating Arm, the Horizontal Arm and the Cone.

Control Unit

The Control Unit provides for the input power connection and control of the Tubehead

and Operator Panel. It provides automatic line voltage compensation, kVp control and

exposure time control. The Control Unit consists of the mounting base and Operator

Panel.

Tubehead

The Tubehead contains the x-ray tube, high voltage transformer, and Cone. The

Tubehead is shipped already assembled to the Articulating Arm.

Note: There is a small hole in the plastic handle covering the back of the

Tubehead. Under no circumstances should this hole be blocked as it provides an

air vent to allow the Tubehead oil to expand and contract as the unit is operated.

Articulating

Arm

The Articulating Arm provides the articulation support for the Tubehead and the reach

and coverage of the Tubehead to the patient. The Articulating Arm allows smooth

movement for precise positioning and does not drift or vibrate when left in position.

Horizontal

Arm

The Horizontal Arm helps provide the necessary reach for the JB-70. The Horizontal

Arm pivots smoothly around a shaft inserted in the top of the Control Unit. The

Horizontal Arm contains an access cover to connect the cable from the Horizontal

Arm to the Control Unit. The Horizontal Arm is available in two lengths, one that

provides a 76 inch reach and one that provides a 66 inch reach.

Cone

The Cone establishes the distance from the x-ray tube to the patient’s skin. It

provides positioning assistance and collimates the x-ray beam to within a defined

circle at its end. The JB-70 is shipped with the standard 8 inch Cone attached to the

Tubehead. A 12 inch Cone (30-A2033) can be ordered as an option.

Installation

and Service

The JB-70 Dental X-Ray System should only be installed and serviced by approved

Progeny dealer personnel. Contact Progeny at (888) 924-3800 if you need assistance

locating an approved dealer.

General Information JB-70

Figure 1

Component

Diagram

General Information JB-70

Compliance with Applicable Standards

Radiation

Protection

The certified components of the JB-70 Dental X-Ray System comply with

Radiation Performance Standards 21 CFR, Subchapter J, at the time of

manufacture.

The certified components of the JB-70 Dental X-Ray System comply with IEC

60601-1-3 Radiation protection/x-ray equipment.

UL 2601-1 File

Number:

E181750

Classified by Underwriters Laboratories Inc. with respect to electrical shock, fire

and mechanical hazards only in accordance with UL 2601-1, and CAN/CSA

C22.2 NO, 601.1-M90, and to the following particular standards, IEC60601-2-7,

IEC60601-2-28.

EMI/EMC

IEC60601-1-2

Certified Components

120V System

Component

Tubehead

Control Unit

Cone 8 in.

Cone 12 in.

Reference Number

30-A0005

30-A0001

30-A2016

30-A2033

230V System

Component

Tubehead

Control Unit

Cone 8 in.

Cone 12 in.

Reference Number

30-A1007

30-A0003

30-A2016

30-A2033

General Information JB-70

EC Declaration of Conformity

Name and

Description of

Product

Progeny JB-70

Catalog

Model

I7017, 76 inch reach, 120Volt

30-A0001, Control, 120Volt

30-A2025, Extension Arm, Long

Catalog

Model

I7016, 66 inch reach, 120Volt

30-A0001, Control, 120Volt

30-A2034, Extension Arm, Short

Catalog

Model

I7027, 76 inch reach, 230Volt

30-A0003, Control, 230Volt

30-A2025, Extension Arm, Long

Catalog

Model

I7026, 66 inch reach, 230Volt

30-A0003, Control, 230Volt

30-A2034, Extension Arm, Short

Class: IIb

Reference

Numbers to

which

Conformity is

Declared

The following regulatory documents apply:

21CFR

UL 2601-1

IEC 60601-1-2

IEC 60601-1-3

IEC 60601-2-7

IEC 60601-2-28

IEC 60601-2-32

Medical Device directive

ISO 13485

EN46001

Declaration

Progeny, Inc. declares that the products described herein meet all the applicable

Essential Requirements of the EC Medical Device Directive 93/42/EEC in Annex

I. For Class IIb products described herein, the product is manufactured,

inspected, tested and released in accordance with the approved quality

assurance system established in accordance with ISO 9001, EN 46001 and

Annex II of the EC Medical Device Directive under the Supervision of the British

Standards Institution, a Notified Body carrying the Notified Body No. 0086.

Contact

Alan Krema

Product Development

Progeny, Inc.

General Information JB-70

Safety

Radiation 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 6ft. (2m) from the focal spot and the X-

ray beam for operator protection.

•Full use must be made of all radiation safety features on the 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.

Electrical Safety

•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 concerning provisions of an additional protective earth (ground)

terminal for power supply connection.

•Before cleaning or disinfecting, this equipment must always be disconnected

from the main electrical supply.

•The JB-70 Dental X-Ray System 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.

Explosion

Safety

This equipment must not be used in the presence of flammable or potentially

explosive gases or vapors, which could ignite, causing personal injury and/or

damage to the equipment. If such disinfectants are used, the vapor must be

allowed to disperse before using the equipment.

Authorized Representatives

North America

PROGENY DENTAL

1407 Barclay Blvd.

Buffalo Grove, IL 60089

Phone: 888-924-3800

Fax: 847-459-5175

Europe

CE Partner 4U

Nijverheidsstraat 5

2624 BA Delft

Netherlands

Phone: +31-15.2576682

Fax: +31-15.2576683

General Information JB-70

Explanation of Symbols on Technical Labels

Type B: Protection against electric shock (IEC 60601.1-1988)

Consult written instructions in User’s Manual.

ATTENTION RAYONS-X:

OPERATION SEULEMENT PAR DU PERSONNEL AUTORISE. VOIR MANUEL

DE L’OPERATEUR.

WARNING X-RAY

THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR

UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS

ARE OBSERVED.

X-RAY EMISSION

Mains HOT WIRE

Mains NEUTRAL WIRE

Earth Ground

Obtaining Technical Support

Contact

PROGENY DENTAL

1407 Barclay Blvd.

Buffalo Grove, IL 60089

Phone: 888-924-3800

Fax: 847-459-5175

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