ARDET ORIX 70 User manual

Pag. 1
OPERATING INSTRUCTIONS
ORIX 70
CONTENTS
GENERAL INFORMATIONS
Introduction
pag. 3
General conditions of warranty
pag. 4
Laws to follow (for Italy only)
pag. 5
Warnings
pag. 6
Ionizing radiations
pag. 7
General protection against x-rays
pag. 7
Ambient and use conditions
pag. 7
Reference rules
pag. 8
Description of the x-ray equipment
pag. 9
Technical data ORIX-70
pag. 10
Technical data SELEMATIC
pag. 11
Fuse table SELEMATIC
pag. 11
Identification labels and their settings
pag. 12
X-ray tubehead
pag. 15
Digital x-ray control board SELEMATIC
pag. 15
USER’S MANUAL
Instructions for use - SELEMATIC
pag. 18
Programmed exposure times
pag. 21
Radiographic techniques: Bisector technique
pag. 22
Radiographic techniques: Long cone technique
pag. 24
Typical inconveniences of intra oral films
pag. 27
Storage of the film
pag. 29
Dark room
pag. 30
Ordinary and special maintenance
pag. 33
Cleaning and disinfection
pag. 33
Instructions for use –E-Arm
pag. 34
INSTALLATION MANUAL
Installation procedure
pag. 35
Packing (card box packing, American type)
pag. 36
Shipment and storage
pag. 36
Description of the equipment
pag. 37
Tools needed for installation
pag. 38
Mounting procedure
pag. 38
Electrical requirements
pag. 40
General diagram
pag. 41

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OPERATING INSTRUCTIONS
ORIX 70
Assembly x-ray generator and pantograph arm
pag. 45
Friction adjustment
pag. 47
Double jointed spring pantograph arm
pag. 48
Technical checkings
pag. 50
Possible troubles and their solutions
pag. 51
Spare parts
pag. 53
X-ray control electric drawing
pag. 54
General electric drawing
pag. 55

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OPERATING INSTRUCTIONS
ORIX 70
GENERAL INFORMATIONS
INTRODUCTION
The ORIX-70 x-ray medical equipment is designed for radiographic diagnosis in the dentistry field
ARDET Dental & Medical Devices s.r.l. declines all responsibilities for damages caused by an
improper use.
Read carefully the following instruction manual before using the equipment.
The equipment conforms with the safety codes in force.
The electrical security of the unit is granted only if it is connected to a regular grounding conductor
Any servicing should be carried out by ARDET’s Dental & Medical Devices s.r.l. qualified
personnel.
Disconnect the equipment, releasing the main switch, during maintenance service.
ARDET Dental & Medical Devices s.r.l. in order to continually develop its equipments reserves the
right to make changes without.
NO PART OF THIS MANUAL IS TO BE REPRODUCED, STORED IN A RETRIVAL
SYSTEM OR TRANSMITTED IN ANY FORM OR IN ANY MEANS, WITHOUT THE
PRIOR WRITTEN PERMISSION

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OPERATING INSTRUCTIONS
ORIX 70
GENERAL CONDITIONS OF WARRANTY
ARDET Dental & Medical Devices s.r.l. guarantees its dental equipments against possible defects
of production for a period of twenty-four (24) months from date of shipment and/or invoice
The x-ray tube installed follows the warranty conditions issued by the manufacturer.
During this period, in case of defects, the client must return back to ARDET Dental & Medical
Devices s.r.l. the material, adequately packed, at his own expense. ARDET Dental & Medical
Devices s.r.l. qualified personnel will check and replace the damaged parts.
All the forwarding of goods in guarantee charged to ARDET Dental & Medical Devices s.r.l. , if
they have not been previously agreed and confirmed in writing, will be returned to the sender.
Guarantee expires in case of:
•Accidental breakage
•Carelessness
•The electrical wiring does not conform with the standards in force
•Incorrect installation
•Incorrect use or observation of the conditions specified in the present manual
•Bad maintenance
•Use of no original components
•Modifications and/or repairs which have not been authorized or which have been
carried out by unqualified personnel
Any probable disputes do not allow customers to withhold payments and do not allow extension to
what previously agreed upon.
.
Our customers are recommended not to use parcel post, especially for the x-ray tube head. We will
not accept any parcel which will reach us damaged or in bad conditions.
Any controversies comes under the jurisdiction of the Court of Milan
.

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OPERATING INSTRUCTIONS
ORIX 70
LAWS TO FALLOW (FOR ITALY ONLY)
OGGETTO: POSSESSO E/O IMPIEGO DI GENERATORI DI RADIAZIONI IONIZZANTI
1) Inviare entro 10 giorni denuncia di detenzione dell’apparecchio ai sensi dell’art. 92 DPR
185/64 alla ASSL territorialmente competente e, nel caso di presenza di lavoratori dipendenti,
come specificato dall’art. 60 DPR 185/64 anche all’Ispettorato Provinciale del Lavoro. Alla
denuncia di detenzione dovrà essere allegata una planimetria in scala 1:50 dei locali nel quale
l’apparecchio è installato con l’indicazione della destinazione dei locali adiacenti e della
consistenza delle opere murarie unitamente alla relazione tecnica redatta da parte dell’E.Q.
(Esperto Qualificato) che contenga la descrizione dell’apparecchio e dei mezzi di
radioprotezione posti in atto.
2) Predisporre le misure necessarie per evitare che la popolazione sia esposta al rischio di
Radiazioni Ionizzanti superiori alle dosi massime ammissibili (art. 95 DPR 185/64).
3) Assicurare la sorveglianza fisica della protezione a mezzo di un E.Q. che ha il compito di
effettuare la delimitazione della zona controllata con l’applicazione dei relativi contrassegni;
l’esame preventivo e periodico del progetto d’impianto; il controllo periodico dell’efficacia dei
dispositivi tecnici di radioprotezione; la valutazione periodica delle esposizioni e delle dosi
individuali assorbite dagli eventuali lavoratori e il rilascio del benestare radioprotezionistico
che dovrà essere rinnovato con periodicità annuale (art. 70 e 72 DPR 185/64).
4) Pagare la Tassa Regionale annuale a mezzo C/C. intestato alla Tesoreria della Regione.
5) Denunciare entro 30 giorni dalla data di installazione l’impiego dell’apparecchio all’
I.N.A.I.L.
L’assicurazione I.N.A.I.L. per i Medici è obbligatoria per Legge e l’omissione o la tardata
presentazione della denuncia è punibile con ammende di importi elevati.

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ORIX 70
WARNINGS
Certain instructions are preceded by “WARNING” with a triangle at the side. Whenever this
symbol appears, carefully read the relevant paragraph before performing any operations
Type of protection against direct and indirect contacts: class II Degree of
protection against direct and indirect contacts: unit with applied part type B.
CAUTION!
Consult the technical documentation provided
Earth connection
~
Alternating currents
ON
OFF
Ionizing radiations
Source of radiation
X-ray control
Equipment which conforms with the EEC Directive 93/42 standards.

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OPERATING INSTRUCTIONS
ORIX 70
IONISING RADIATIONS
X-rays are harmful, if improperly used. Therefore, the instructions contained herein must be strictly
observed.
ARDET Dental & Medical Devices s.r.l. produces x-ray equipments which conform with the most
restrictive worldwide rules of radio protection in force.
Aim of an x-ray equipment is the emission of x-rays for medical diagnosis by means of a film or an
“Imaging” system.
In any case, independently from the safety of our equipments, we suggest you to protect yourself
and your patient from the spread radiations (secondary radiations).
GENERAL PROTECTION AGAINST X-RAYS
a) Control x-ray emission at a distance of at least 2 meters from the focal spot and the x-ray beam.
b) Reduce, as most as possible, the radiation level to which the patients and operating personnel
are exposed.
c) During x-ray emissions, only the operating personnel and the patient must be present.
d) In case it should be necessary to help patient to hold the film in position, the operating personnel
must use appropriate tools and wear anti radiation gloves and apron to protect hands and body.
In any case, the patient must always be protected with a lead apron 0,25 mm. min.
Operations which produce x-ray emission are preceded by symbol “Ionizing Radiation” as to
remember all the conditions to observe in compliance with the rules in force in your Country.
AMBIENT AND USE CONDITIONS
The room where the x-ray equipment is to be used should satisfy the following conditions:
1) Temperature between 10 and 40° C.
2) Relative humidity from 30 to 75%
3) Atmospheric pressure from 700 to 1060 hPa.
4) The electrical wiring must conform with CEI 64-8 (the regulations concerning the electrical
wiring to be used in surgery)

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OPERATING INSTRUCTIONS
ORIX 70
5) Concerning the protection against radiation, the room must conform with the regulations in
force in the country where the equipment is used.
6) Before leaving the surgery, turn the main switch to the OFF position.
CAUTION!
7) The equipment is not liquid-proof (traditional equipment)
8) The equipment is not suitable for use in presence of flammable anesthetic gas based on oxygen
and nitrogen protoxide
9) If an electric bistoury or other electrical equipments which do not conform with CEI EN
60601-1-2 specifications are used in surgeries or nearby, interferences or disturbances may
arise thus causing the x-ray equipment to malfunction. In this case, disconnect the x-ray
equipment before using any other instruments or device.
10) The ORIX-70 x-ray generator contains mineral oil, which is classified as a special by-product.
Therefore, when the generator is to be put out of service it should be sent back to the
manufacturer or given to a company authorized to dispose of mineral oil and the special by-
products.
REFERENCE RULES
The ORIX 70 dental x-ray equipments conform with the following rules:
CEI EN 60601-1 (2007) Third edition + Corr. IEC:2007+IS IEC:2008 –Medical electrical
equipment - Part 1: General requirements for basic safety and essential performance
CEI EN 60601-2-7 (1999)- Medical electrical equipment - Part 2: Particular requirements for the
safety of high-voltage generators of diagnostic X-ray generators
CEI EN 60601-1-2 (2007) Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests
CEI EN 60601-1-3 (1998) Medical electrical equipment. Part 1: General requirements for safety. 3:
Collateral standard: General requirements for radiation protection in diagnostic x-ray equipment.
CEI EN 60601-2-28 (1998) Medical electrical equipment - Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
Directive EMC 2004/108/CE Electromagnetic compatibility

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OPERATING INSTRUCTIONS
ORIX 70
DESCRIPTION OF THE X-RAY EQUIPMENT
DESCRIPTION
1X-RAY GENERATOR (TUBE HEAD)
2CENTERING CONE FSD 20 CM.
3COUNTER BALANCED ARM
4X-RAY CONTROL
5REMOTE CONTROL
6BASE WITH WHEELS
7COLOUMN

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OPERATING INSTRUCTIONS
ORIX 70
TECHNICAL DATA ORIX-70
Main 230 VAC +/- 10% - 50 Hz.
Primary consumption 6 A. max at 230 VAC
Total consumption 1380 VA. - 230 VAC
Line impedance 0.8 Ohm
Rated high voltage 70 KVP
Power rating 0,414 KW - 230 VAC
Actual power rating 0,450 KW - 230 VAC
X-ray tube: type and manufacturer OCX 65 G grid type - CEI srl, Bologna
Anode Tungsten (W)
Anodic inclination 19° in relation to the reference axis
X-ray tube current 8mA.
Focal spot mm. 0,8 x 0,8 (I.E.C.)
Tolerance on the reference axis of focal spot position +/- 1°
Inherent filtration Equivalent to mm. 0,5 AL
Total filtration = or > at mm. 2,5 AL.
Limiting device cylindrical type
Irradiated field diam. mm. 55 (when it reaches the skin)
Internal protection in Pb. - 0,3 mm. equivalent.
Focus-Film distance mm. 200
Transformer insulation oil bath
Cooling ambient
Use x-ray equipment for continuous operating with intermittent load
Load (Duty cycle) 1 at 30
Radiation leakage < 28 mR/h. at 50 cm. distance
Technical factors for x-ray leakage 70 Kv. - 8 mA. - 1 cycle
Current reference - time factor 0,1 s x 8 mA. 0.8 mA/s.
X-ray tube OCX 65 G
Datum line and anode inclination angle