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HBE060-1 Evostyle ING
HBE060-1 Evostyle ING
HBE060-1
RADIOLOGY srl
Mod. MQI006-0 User and Installation Manual Page 1 of 21
EVOSTYLE
EVOLUTION:
EVOSTYLE Model
CONTENTS
1) Introduction
2) Description
3) Safety aspects
4) Technical data on Evostyle Model
5) Mode of use
6) Type of installation
7) Timer
8) X-ray tube
9) Possible problems arising in the results of intra-oral x-rays
10) Exposure times
1. INTRODUCTION
Dear Customer,
We thank you for having chosen our product and invite you to read the instructions contained in this manual
very carefully, as they will help you to obtain the maximum diagnostic information from your radiographs with
the minimum use of x-rays.
This manual is designed to provide the User with the necessary instructions for proper, safe and efficient
operation of the equipment.
The equipment must be used in compliance with the procedures set down in this manual and must under no
circumstances be used for purposes other than those specified.
The User is responsible as regards the legal requirements concerning installation and operation of the
equipment.
The system can only be used by medical personnel having the relative qualifications and aware of the risks
related to the use of ionizing radiation sources. The use of X-ray sources for medical diagnostic purposes is
subjected to specific authorizations and/or communications to the surveillance Bodies in charge. The user is
responsible for the non-authorized use of the system. The user of the of the X-ray system for dental
complementary radiology is subjected as well, without exception, of observing the laws regulating the
security from the exposition to ionizing radiation sources for the workers, the public, for the population and
for the patients
If the apparatus were not to be operated properly or if no adequate maintenance is carried out, the
manufacturer cannot be considered in any way responsible for possible failures, injuries or malfunctioning.
2. DESCRIPTION
The EVOSTYLE x-ray unit is a piece of equipment designed for enabling tooth x-rays and dental
examination through images displayed on a monitor..
For the EEC 93/42 Directive, is classified as follows: Class IIb.
The apparatus is built in compliance with current international standards regarding electrical safety
(protection against ionizing radiations), mechanical safety and electromagnetic compatibility of electro-
medical equipment.
The apparatus consists of:
* Enbloc head assembly
* Pantographic articulated support, with wall attachment
* Timer
The apparatus is equipped with an automatic fuse system which goes into action in the case
of danger of exposure to radiation different from the specified times or doses.
Should the fuse burn, the apparatus blocks and automatically detaches the part connecting
! up with the enbloc head, at the same time keeping the timer in operation, so that it can no
longer send signals to the enbloc head.
In such cases, switch off the apparatus and call in the Technical Assistance Service.
The fuse cannot be repaired and must be replaced by a qualified technician.
3. SAFETY ASPECTS
- The apparatus is not designed for use in the presence of explosive gases or vapours.
- Water or other liquids should not be allowed to enter the apparatus in order to prevent any short-circuits or
corrosion.
- Only qualified and technical staff is authorized to remove the enbloc assembly from its support.
- The staff authorized to carry out x-ray examinations must observe rules for protection against radiation.
- To protect the patient from the scattered radiation, the use of protective clothing must be considered.
- While x-ray examinations are being carried out, no other people should be present in the room apart from
the patient.
- During x-ray emission, the operator must never touch the covering of the enbloc, nor the relative collimator
cone, and if he cannot position himself in an area protected by shields, he must keep at the maximum
distance opposite the radiating beam.
- The x-ray plate must be positioned in the oral cavity of the patient, and must be held in place by the patient
himself.
Earth protection
Alternating current
Ionizing radiation
Switch open
O (disconnected from mains supply) I Switch close (connected to mains supply)
Outside:
Inside: Outside: PANTOGRAPH
T033 Caution T035 ARM ARM T036
Outside:
T002 Fuses
Outside:
RX EVOSTYLE
Outside:
TIMER
Outside: Outside:
KFI003 LONG CONE
radiation symbol
5. MODE OF USE
The apparatus is designed for continuous operation with intermittent load. The operation
! times are with intermittent load 1:60.
(1 s ON : 60 s OFF)
General
Classification
- Degree of protection against direct and Apparatus with Type B parts applied
indirect contacts:
- Degree of protection against penetration of Ordinary apparatus IPX0
water:
- Degree of safety of use in the presence of Apparatus not suitable for use in the presence of
inflammable anaesthetic mixture: anaesthetic mixture inflammable with air or with oxygen or
with nitrous oxide
- Conditions of use: Apparatus for continuous operation with intermittent load
- Installation: Permanent
Type of enbloc
6. TYPE OF INSTALLATION
The equipment is designed to be permanent.
INSTALLATION PROCEDURE
WALL-MOUNTED VERSION
1) Define on the wall the position of the WALL PLATE with respect both to the extent of the working range
chosen and to the overall dimensions of the structure which the latter may occupy to the right or to the left of
the axis of the wall plate when it is not in use.
2) Trace out on the wall the position of the six holes, using the CARDBOARD TEMPLATE. Use a plumb line
to make sure that it is perpendicular. If the electrical wiring is set into the wall, also trace out the
corresponding hole required.
3) Make six holes in the wall starting with a ∅7 drill, widening out the holes progressively. Proceed in this
way so as not to destroy the stability and so as to keep the distance between centres under control. For
walls made of full or hollow brick, or of cement, use metal anchor bolts, preferably of ∅12, provided with
unlosable expander nut and separate hexagonal-head screw ∅6 and washer.
For types of walls that present poor reliability, you must provide a suitable reinforcement, as required.
4) Apply the wall plate, bringing it up parallel to the wall and tightening the 6 screws crosswise. If the wall
were not perfectly flat, interpose suitable shims so as not to cause deformation of the wall plate.
5) After carrying out assembly and dynamic testing of the entire apparatus, you are recommended to check
that the screws are tight so as to eliminate any play that might have arisen between the wall and the plate.
6) insert the prolongation arm in the wall plate
7) put the cable inside the prolongation arm
8) insert the front plug on the prolongation arm
9) connect the brown and blue wires on the thermoswitch
10) connect the yellow-green wire on the electronic board on earth mark
11) connect the power wire on the input 230V inside the electronic board
12) close the Timer cover using 4 screws
CALIBRATION SPRING
N.B. The double pantograph arm, is supplied with a spring calibration adequate for the enbloc's weight.
Otherwise, for little corrections, follow these instructions:
- remove the plastic cover
- rotate on clockwise the nut "A and B"
ENBLOC ASSEMBLY
With reference to the fig. 3 is necessary carry out the follows enbloc assembly:
- hoist the ring "C" bottom-up
- extract the key "F" from point "G"
- insert the bushing "I" in support "K"
- insert the key "F" on groove "G"
- lower the ring "C"
Electrical specifications
All the work for the electric power supply system must be carried out according to the reference standards
currently in force for electric wiring and premises for medical use (CEI 64-8-710).
The required power supply is 230V/240V - 50 Hz. For the live, neutral and earth conductors, the minimum
section must be 1.5 mm2 of copper. It is absolutely essential to make an adequate earth connection in
accordance with current legal requirements.
The electric wiring system must be carried out and tested by qualified staff.
Any damage resulting from faulty connection is excluded from the warranty.
PRECAUTIONARY MAINTENANCE
Must be done by the dental laboratory's operator at least once a year.
We supply indications for scheduling ordinary maintenance on the system by completely exploiting the
diagnostic potential, without compromising any security and reliability aspect that distinguish the Company.
The checks and verifications are divided in blocks and the operator before starting the control procedure
must make sure to have the instructions manual available:
- x-ray head enbloc:
tag integrity with identification data
signposting of ionizing radiation danger integrity absence of oil leaks verification
complex integrity, covering shells, connection of the spacer cone, rotation system
enbloc correct anchorage to the pantograph verification
verify the correct 360° enbloc rotation
- wall support and pantograph:
correct fastening of the support verification
move in all directions the pantograph to verify its stability and balancing
verify that the complex's movement is flowing, flexible, without obstacles and that it is not hardening
verify the presence of fluidifyin liquid wiredrawings
- power supply control unit
tag with identification data integrity
trigger control integrity and relative spiral cable verification
warning lights (yellow) integrity
acoustic warning system integrity
During the above recommended verifications that must anyway be intended as indicative of a minimum to
ensure the system's efficiency, but can be subjected to development, any abnormality must be reported to
the service technician of your distributor New Life Radiology for the necessary interventions (extraordinary
maintenance not by the operator)
EXTRAORDINARY MAINTENANCE
By New Life Radiology srl's service technician when needed and anyway after each relevant intervention or
repair.
General indications on minimum checks and verifications are provided that are intended as performed at
each technical intervention on the system:
- enbloc, support and pantograph stability
- wear and tear of the rotation joints, of the system balancing and of the springs
- head frictional contact of the power supply
- head and power supply control unit power supply cable
Responsibility of manufacturer
The manufacturer is responsible for the safety, reliability and performance of the apparatus only provided
that:
a) the assembly and any interventions on the apparatus have been carried out by persons authorized by
the manufacturer;
b) the electrical system of the premises in which the apparatus is installed is in compliance with current
standards regarding electrical system safety;
c) the apparatus is used in compliance with the user instructions.
Cleaning and disinfection of the apparatus and the parts coming into contact with the patient
The apparatus must always be disconnected from the electric power supply before any cleaning and/or
disinfection operations are undertaken.
The method used for disinfection must correspond to current regulations and recommendations, including
those regarding the prevention of risks of explosion.
A) Cleaning and disinfection of the parts coming into contact with the patient
1) The part that comes into contact with the patient is the collimator cone (Code CL01). This part must be
disinfected thoroughly after use with disposable disinfectant wipes of the "medical and surgical dressings
and appliances" category.
Environmental protection
The enbloc assembly of the apparatus consists of parts made of lead and contains oil. The disposal of these
components at the end of their service life must take place under control at authorized waste-disposal firms
according to current standards and regulations.
In the event of damage to the enbloc assembly due to impact or crushing, with consequent leakage of oil,
make sure that the oil is not scattered in the environment, but dispose of it as indicated above.
Technical description
7. TIMER
• The timer of the apparatus is a control panel for managing operation times and for controlling safety of
the enbloc head assemblies for intra-oral radio-diagnostics.
• The front panel with digital membrane keys enables ease of reading and immediate use of the selection
of the x-ray time.
• The "deadman" push-button enables intervention beyond the safety limits prescribed by current
regulations.
• The timer does not allow use of x-rays for radioscopy.
Switching-
on
Switch on the apparatus by operating switch
The display (1) indicates that the apparatus is switched on and ready for use.
Selection
When the machine is turned on ,all of the led will glitter three times. In the mean time ,the machine will enter
into the auto-test program automatically after one beep. Eventually anomalies, will be visualize with error
code on display (1). Control the follow error code table. When you start the machine ,it will enter into the
voltage surveillance program by pushing any button for a while. This voltage function only can check the
voltage between 190VAC and 264VAC.It will display A6 or A7 code if the voltage is lower and higher .
After it enter into cycle the control panel will adjust the mode of the adult’s cheek tooth automatically. During
this cycle you can choose the adult’s cheek tooth (11), front cheek tooth (10), canine tooth and incisor (9) by
pushing the adult’s button (8). In the mean time the indicating light that correspond to chosen tooth led, will
be light. You also can choose the children’ cheek tooth (17), front cheek tooth (16), canine tooth and incisor
(15) by pushing the children’s button (7).The indicating light will be light after choosing. Every choice will
NEW LIFE RADIOLOGY S.R.L.
Via Latina 17 10095 GRUGLIASCO (TO) Italy
PHONE + 39.11. 781994 - FAX. + 39. 11.7801732
NEW LIFE Manual: Doc. HBE060-0
RADIOLOGY srl
Mod. MQI006-0 User and Installation Manual Page 14 of 21
EVOSTYLE
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Recommendations
To achieve maximum quality of the x-ray image with the minimum dosage of radiation, you are
recommended to use high-sensitivity films and to adhere to the developing times as suggested by the
manufacturer of the films, constantly shaking the films during developing. If the image thus obtained is too
dark, decrease the time of exposure to x-rays, and not the duration of the developing.
In the case of manual developing, remember that the developer retains its efficiency on average for one
week, regardless of the number of films treated. Also remember that the treatment liquids are harmful for the
environment and must be disposed of according to the manufacturer's directions.
The Values set on the timer and displayed by the relative display are extracted from table R'10 of the EN-
60601-2-7 (IEC 60601-2-7) law.
The reference timings to set the timer must be registered from the instructions provided by the film and/or
digital system used of the manufacturer.
90°
Block diagram
This block diagram indicate the flow of connection for correct use of Timer.
The feeding cables, those of exit lamp and those of x-ray tube, must be close to the hose clamp; verifying
that the mentioned cables are very blocked after this operation.