Gendex 765DC Manuale utente
765DC
Intraoral x-ray system
USER MANUAL 1-17
Intraorales Röntgengerät
BENUTZERHANDBUCH 18-34
Sistema radiográfico intrabucal
MANUAL DEL USUARIO 35-51
MANUEL DE L'OPÉRATEUR
de l'appareil de radiographie intra-orale 52-68
Sistema radiologico intra-orale
MANUALE D'USO 69-85
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Table of Contents
General Description ……………………………… Page 2
Identification Labels ……………………………... Page 3
Compliance with Applicable Standards …………... Page 4
Explanation of Symbols on Technical Labels ……… Page 6
Safety …………………………………………….. Page 7
Operating Controls ………………………………. Page 8
Operating Procedure ……………………………... Page 9
Configuring Control Settings ……………………. Page 10
Default Exposure Tables ………………………... Page 12
Error Display and Conditions …………………… Page 13
System Specifications ……………………………. Page 14
Recommended Maintenance …………………….. Page 17
Cleaning and Disinfecting ………………………. Page 17
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765DC INTRAORAL X-RAY SYSTEM
GENERAL DESCRIPTION
This User Manual is intended to assist the Operator in the safe, and effective operation of
the 765DC high frequency Intraoral x-ray system. It contains the information necessary to operate
the equipment, the technical specifications, and the procedures to perform its simple maintenance.
Before attempting to operate the equipment, read this manual thoroughly. Pay particular attention
to all Warnings and Cautions incorporated in it.
The original language of this manual is English.
SYSTEM COMPONENTS
SUSPENSION
Allows the tubehead
to be positioned with a
reach of 55" (140cm),
65" (165cm) or
75"
(
191cm
)
MASTER CONTROL
Allows anatomical
setting of time.
Single button selection
of adult or child.
Single button selection
of film or digital.
CONE
Standard 8" (20cm)
focal length.
Optional 12" (30cm), or
20 cm rectangular
collimation.
TUBEHEAD
Focal spot indicated by
bump on cover.
Secondary operator
controls.
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IDENTIFICATION LABELS
The 765DC Tubehead, Master Control, and Cone have identification labels that specify
the model number, serial number and applicable product approval listings. On specified
components, subject to U.S. Government Radiation Performance Standards 21 CFR, Subchapter
J, a certification statement is included with other required information.
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COMPLIANCE WITH APPLICABLE STANDARDS
The 765DC complies with the following standards:
General (electrical/mechanical) safety:
UL60601-1 File Number: E185414
MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 NO,601.1-M90, AND TO THE FOLLOWING PARTICULAR STANDARDS,
IEC60601-2-32, IEC60601-2-7 IEC60601-2-28, IEC60601-1-2.
Radiation protection IEC60601-1-3 Radiation protection/x-ray equipment.
The certified components of the 765DC system comply with Radiation Performance
Standards 21 CFR, Subchapter J, at the time of manufacture.
The equipment must only be installed, and operated in accordance
with the safety procedures and operating instructions given in this User
Manual and in the Installation/Maintenance Manual for the purposes and
applications for which it was designed. Modifications and/or additions to the
equipment may only be carried out by Gendex or by third parties expressly
authorized by Gendex to do so. Such changes must comply with legal
requirements as well as with the generally accepted technical rules. It is the
responsibility of the user to ensure that existing legal regulations regarding
installation of the equipment with respect to the building are observed.
IMPORTANT! …… X-RAY PROTECTION
X-ray equipment may cause injury if used improperly.
The instructions contained in this manual must be read and followed when
operating the 765DC. Your Gendex dealer will assist you in placing the 765DC in
operation.
The 765DC intraoral x-ray system provides a high degree of protection from
unnecessary X-radiation. However, no practical design can provide complete
protection, nor prevent operators from exposing themselves or others to
unnecessary radiation.
34SL
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Authorized Representative:
GENDEX Dental Systems s.r.l. GENDEX Dental Systems
Via A, Manzoni 44 901 West Oakton Street
20095 Cusano Milanino - Mi Des Plaines, IL 60018-1884
Tel: +39.02.61800.81 Tel: (847)640-4800
Fax: +39.02.61800.809 Fax (847)640-4891
EC Declaration of Conformity
A. Name/Description of product:
Gendex 765DC Intraoral X-Ray System
REF: Model 110-0154G1,G2,G3
Class: IIb
B. Reference Standards under which conformity is declared:
IEC60601-1:1988 +A1:1991 +A2:1995
IEC60601-1-1:2000
IEC60601-1-2:2001 IEC60601-2-28:1993 IEC60522:2003
IEC60601-1-3:1994 IEC60601-2-32:1994 IEC60878:2003
IEC60601-1-4:1996 IEC60336:2005 EN 980:1997
IEC60601-2-7:1998 IEC60417:1973 ISO14971:2000
C. GENDEX Dental Systems, 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.
John R. Miller
Director of QA/RA
GENDEX Dental Systems
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EXPLANATION OF SYMBOLS ON TECHNICAL LABELS
Type b: Protection against electric shock (UL60601-1:2003)
Consult written Instructions in this Operator’s Manual
X-RAY SOURCE Assembly
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
Electronic Equipment
No recycle into normal trash
Classification
The 765DC is a UL Class I Type b equipment (UL60601-1:2003).
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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 features on the equipment, and of
all radiation protection devices, accessories, and procedures available to protect
the Patient and Operator from x-ray radiation.
Electrical safety
Covers on the equipment should only be removed by qualified and
authorized service personnel.
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.
This equipment must always be electrically disconnected from the mains
electrical supply before cleaning or disinfecting.
ORDINARY MEDICAL EQUIPMENT without protection against ingress
of liquids. No water or any other liquid should be allowed to leak inside the
equipment, as they may cause a short-circuit and corrosion.
Explosion safety
This equipment must not be used in the presence of flammable or
potentially explosive disinfecting 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
Mechanical safety
Where complete safeguarding of the equipment is not possible, due care
must be taken to ensure that no part of the user’s or patient’s body or clothing
can be trapped or injured by any part of the equipment. In particular, make sure
that fingers are not caught or pinched in the articulated arm when closing it.
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OPERATING CONTROLS
1. TIME SELECTION - Allows the
operator to override the anatomical
preset time and adjust the exposure time
up or down to a specific value on the
R10 scale.
2. ANATOMICAL TIME SELECTION
- Allows the operator to select the
exposure time based on the tooth area
desired.
3. IMAGING TYPE SELECTION - A
toggle function that allows the operator
to select between the use of film or a
digital imaging system. This will modify
all of the preset anatomical time
selections.
4. PATIENT SELECTION - A toggle
function that allows the operator to
select either an adult or a child. This will
modify all of the preset anatomical time
selections.
5. READY INDICATOR LAMP -
Indicates that the "On" switch has been
pushed and the system is ready for
operation.
6. COOL-DOWN INDICATOR LAMP -
This lamp will light when the duty cycle
of the system requires that the tubehead
cool before the next exposure.
7. RADIATION INDICATOR LAMP -
This lamp will light when the exposure
button is pressed indicating that x-ray
radiation is being produced.
8. PUSH-BUTTON EXPOSURE
SWITCH - Allows the operator to
initiate the exposure directly from the
control panel when it is mounted outside
the operatory.
9. COIL-CORD EXPOSURE SWITCH
(Optional – Not Shown) - Allows the
operator to exit the operatory and then
initiate the exposure.
10. SECONDARY TUBEHEAD
CONTROLS - This allows the operator
to verify and adjust if necessary the
anatomic exposure times directly at the
tubehead. A lamp also indicates whether
the adult or child setting has been
selected.
11. POWER SWITCH - Depressing the
switch to the "on" position will supply
power to the control. The Ready
Indicator Lamp on the control panel will
indicate that the system is ready for use.
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OPERATING PROCEDURES
1. Switch the power switch to the "On" position. The Ready indicator lamp on the front
of the control panel will light.
2. Select or verify that the unit is set for either film or digital imaging. The indicator
light should be lit next to the appropriate graphic icon. Press the button between the
two icons to toggle to the correct selection.
3. Select or verify that the system is set for the appropriate patient selection (i.e. an adult
or child). Press the button between the two icons to toggle to the correct selection.
4. Press the selector button in the center of the control to toggle the indicator lamp until
it lights next to the tooth (or bitewing) symbol for the area that you wish to x-ray.
Note: The exposure time defaults (the times displayed when the system is initially
turned on) can be modified per the instructions in the Configuring Control Settings
section on page 10.
5. If desired, the up or down buttons can be used to select a specific exposure time other
than the default setting using the R10 scale. For recommendations for Occlusal film,
see the Default and Recommended Exposure Tables on page 12.
6. Position the tubehead to the patient using standard accepted positioning procedures.
Note: Care should be taken to not place fingers in areas where they may be
potentially pinched during the movement of the arm. Also, be careful to not have the
tubehead hit the wall after returning the arm to the storage position.
7. Prior to making the exposure, verify or modify the time settings as necessary using
the secondary tubehead controls. Note: The unit is supplied with an 8” (20cm) cone.
An optional longer 12” (30cm) cone can be used to sharpen the image as when the
paralleling technique is used. A rectangular cone is available as an option to reduce
the x-ray field size to that of the film and reduce the radiation to the patient.
8. When using the optional coil-cord exposure switch, it is strongly recommended that
the operator exit the operatory. Note: In order to comply with regulations and good
safety practices, the technique factors must be visible to the operator from the remote
location.
9. Press and hold either the coil-cord or push-button exposure switch until the audible
signal and exposure indicator light terminate. (Note: Releasing the exposure button
at any time will immediately terminate the exposure).
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