Castellini RX DC 706S0463 Usermanual
Castellini RX DC 706S0463 Usermanual
Castellini RX DC 706S0463 Usermanual
REF. 97050907
Rev. 01 - 18.01
RX DC
CEFLA s.c. VIA SELICE PROV.LE 23/A - 40026 IMOLA (BO) ITALY
PLANT: VIA BICOCCA 14/C - 40026 IMOLA (BO) ITALY
EN
ITALIANO
2 OPERATOR'S MANUAL EN
Contents
1. GENERAL WARNINGS ............................................................................................................................................. 5
1.1. SYMBOLS ............................................................................................................................................................ 5
1.2. STANDARDS AND REGULATIONS .................................................................................................................... 6
1.3. INTENDED USE ................................................................................................................................................... 6
1.4. CLASSIFICATION ................................................................................................................................................ 6
1.5. ENVIRONMENTAL CONDITIONS ....................................................................................................................... 7
1.6. WARRANTY ......................................................................................................................................................... 7
1.7. PROTECTION AGAINST RADIATION ................................................................................................................ 8
2. DESCRIPTION OF THE X-RAY DEVICE ................................................................................................................. 9
2.1. INSTALLATION TYPE .......................................................................................................................................... 9
2.2. TYPE OF X-RAY HEAD ..................................................................................................................................... 12
2.3. HANDHELD ........................................................................................................................................................ 12
3. SWITCHING ON AND OFF THE X-RAY DEVICE .................................................................................................. 13
4. HANDHELD FUNCTIONS ....................................................................................................................................... 14
4.1. HANDHELD DISPLAY FUNCTIONS.................................................................................................................. 15
4.2. USE OF HANDHELD ......................................................................................................................................... 16
4.3. CHECKING THE PARAMETERS....................................................................................................................... 17
4.4. FACTORY SETTINGS ....................................................................................................................................... 18
5. USE OF THE X-RAY DEVICE................................................................................................................................. 19
5.1. PATIENT POSITIONING .................................................................................................................................... 19
5.2. POSITIONING THE X-RAY HEAD ..................................................................................................................... 19
5.3. POSITION OF THE X-RAY PLATE OR SENSOR ............................................................................................. 20
5.4. SETTING THE EXPOSURE MODE AND TIME ................................................................................................. 21
5.5. PROCEDURE TO BE FOLLOWED WHEN TAKING THE X-RAY ..................................................................... 23
6. ADVANCED OPTIONS ........................................................................................................................................... 24
6.1. SETTING THE OPERATING MODE .................................................................................................................. 25
6.2. SETTING TYPE OF MOVABLE COLLIMATOR ................................................................................................. 26
6.3. RESTORING FACTORY SETTINGS ................................................................................................................. 26
7. ERROR MESSAGES .............................................................................................................................................. 27
8. PERIODIC MAINTENANCE .................................................................................................................................... 28
9. CLEANING AND DISINFECTION ........................................................................................................................... 29
10. DISPOSING THE EQUIPMENT WHEN NO LONGER USED ................................................................................ 30
11. TECHNICAL DATA .................................................................................................................................................. 31
11.1. X-RAY TUBES ............................................................................................................................................... 33
11.2. TECHNICAL FACTOR MEASURE ................................................................................................................ 34
12. DIMENSIONAL CHARACTERISTICS ..................................................................................................................... 35
13. IDENTIFICATION PLATES ..................................................................................................................................... 39
14. TIMES/SENSITIVITY CHARTS ............................................................................................................................... 41
15. NOMINAL DOSE EMISSION VALUES ................................................................................................................... 42
16. INSPECTION AND MAINTENANCE ....................................................................................................................... 52
16.1. USER INSPECTION ...................................................................................................................................... 52
16.2. TECHNICAL MAINTENANCE ........................................................................................................................ 53
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4 OPERATOR'S MANUAL EN
1. GENERAL WARNINGS
These instructions explain how to correctly use the RX DC x-ray unit. Please carefully read this manual before using
the device.
NOTE: This manual does not specify all the obligations and warnings for possessing a source of ionising
radiation as each country has its own laws. Only the most common ones shall be mentioned and this means
that it is the user’s responsibility to check local standards and observe the relevant laws.
This publication must not be reproduced, copied or transferred in any manner (electronically, mechanically, via
photocopies, translations or other means) without the prior written consent of the manufacturer.
The manufacturer has a company policy of continual development. Therefore, some of the instructions, specifications
and figures given in this manual may slightly differ from the purchased product. The manufacturer reserves the right
to make changes to this manual without giving prior notice.
The original text is in Italian.
Please consult the Web site of the manufacturer to find a list of authorised representatives.
1.1. SYMBOLS
Type of protection against direct and indirect contact: Class I. Level of protection against direct and
indirect contact: TYPE B.
WARNING! Failure to observe may result in equipment damage or injury to the user and/or patient.
NOTE: Indicates information that is especially important for the user and/or assistant.
Alternating current.
On.
Off.
Ionising radiations.
Operating instructions. Consult the enclosed documentation before using the device.
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It is necessary to refer to the user manual.
Pushing prohibited.
Stepping prohibited.
Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-65:2012
IEC 60601-1-6:2010
IEC 62366:2008
The CE marking certifies compliance of the product as described by Medical Device Directive 93/42/EEC and
subsequent amendments.
This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes.
This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used
with digital x-ray sensors.
1.4. CLASSIFICATION
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1.5. ENVIRONMENTAL CONDITIONS
1.6. WARRANTY
The manufacturer stands behind its products warranting safety, reliability and performance. The warranty is valid only
under the following terms:
- Closely observe the conditions specified in the warranty certificate itself.
- The equipment is only to be used as instructed in this manual.
- Equipment installation, expansion and technical support must be performed exclusively by personnel authorised
by the manufacturer to carry out these operations.
- Never open the equipment casing. Installation, repairs and, in general, any other operations requiring the casing
to be opened are to be performed exclusively by personnel authorised by the manufacturer to carry out these
operations.
- The equipment is to be installed in rooms that follow the requirements specified in paragraph 1.2.2.
“Environmental conditions”.
- The room where the x-ray unit is installed must comply with official regulations regarding protection against
radiation in the country where the equipment is used.
SAFETY WARNINGS.
- If any person who is not an authorised technician changes the product in any way by replacing parts or
components with other ones not used by the manufacturer, they shall assume responsibility for the
product.
- Do not forget to turn off the main switch on the equipment before leaving the surgery.
- The equipment is not protected against liquid penetration (risk of electrocution).
- The equipment is not suitable for use in the presence of a mixture of flammable anaesthetic gas with
oxygen or nitrous oxide.
- This equipment must be stored properly so that it is kept in top working order at all times.
- Use of electric scalpels or other electric apparatus that do not comply with standard I.E.C. 60601-1-2, in
the surgery or nearby may cause electromagnetic or other types of interferences resulting in equipment
malfunctions. In these cases shut off the power supply to the equipment beforehand.
- The manufacturer shall not be held responsible for misuse, carelessness or improper use of the
equipment.
- The equipment may only be used by authorised and adequately trained staff (dentists and paramedics).
- The user must be present at all times when the equipment is turned on or ready for start-up. In
particular, never leave the equipment unattended in the presence of children/the mentally disabled or
other unauthorised personnel in general.
- If the x-ray equipment is damaged or oil leaks, do not use the equipment and contact customer service
immediately.
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1.7. PROTECTION AGAINST RADIATION
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2. DESCRIPTION OF THE X-RAY DEVICE
The x-ray unit is available in several versions, which differ in type of installation, x-ray head and handheld.
It is possible to identify the different versions via the REF on the nameplate.
WALL-MOUNTED VERSION
a. X-ray generator.
Constant potential high frequency x-ray generator.
b. Removable collimator (cone).
The generator can work with different types of collimator that are automatically recognised:
- 8” cylindrical COLLIMATOR (incorporated in the generator): minimum skin/focus distance 20cm and 60mm
output beam.
- removable 12” rectangular COLLIMATOR (only for CAEU****S): minimum skin/focus distance 30cm and 45x35
mm output beam (rectangular collimator attached).
- removable 12” round COLLIMATOR (optional for CAEU****S): minimum source/skin distance 30cm and
diameter of collimator output beam 55mm (with collimator attached).
The following rectangular collimators to be attached to a 12” round collimator are also available as optionals:
- rectangular COLLIMATOR 22x35 mm
- rectangular COLLIMATOR 31x41 mm.
c. Focus spot.
d. Double pantograph arm.
e. Extension arm.
The extension arm is available in three length versions: 40 cm (15.7"), 60 cm (23.6") and 90 cm (35.4").
f. Handheld.
The handheld can be placed either near the control unit or in a remote position. As a result, the doctor can move
conveniently around the room and move out of the area where x-rays are emitted.
g. Handheld holder.
h. Control unit.
I - Main switch.
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MOBILE STAND INSTALLATION
c. X-ray generator.
Constant potential high frequency x-ray generator.
d. Removable collimator (cone).
The generator can work with different types of collimator that are automatically recognised:
- 8” cylindrical COLLIMATOR (incorporated in the generator): minimum skin/focus distance 20cm and 60mm
output beam.
- REMOVABLE 12” rectangular COLLIMATOR (only for CAEU****M): minimum skin/focus distance 30cm and
45x35 mm output beam (rectangular collimator attached).
- REMOVABLE 12” ROUND COLLIMATOR (optional for CAEU****M): minimum source/skin distance 30cm and
diameter of collimator output beam 55mm (with collimator attached).
The following rectangular collimators to be attached to a 12” round collimator are also available as optionals:
- RECTANGULAR COLLIMATOR 22x35 mm
- RECTANGULAR COLLIMATOR 31x41 mm.
c. Focus spot.
d. Double pantograph arm.
e. Handheld.
The handheld can be placed either near the control unit or in a remote position. As a result, the doctor can move
conveniently around the room and move out of the area where x-rays are emitted.
f. Handheld holder.
g. Control unit.
h. Main switch.
WARNING!
Never move the mobile stand x-ray unit without first securing the support arm with the special strap.
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To move the mobile stand x-ray unit:
1) Unplug the x-ray unit power cord from the power supply.
2) Place the power cord so that it does not get in the way.
3) Always secure the support arm with the associated safety belt.
4) Move the x-ray unit carefully using the handles.
WARNING!
Moving the mobile stand x-ray unit without using the handles can cause the device to fall, unbalance or tip
over. Be very careful and always use the handles.
WARNING!
During the movement of the mobile stand, pay attention to the presence of steps and / or horizontal
obstacles as they may cause a situation of instability and / or tip over the cart. If you wish to move the x-
ray over a small obstacle, gently tilt the base by pressing with your foot near the rear wheels.
WARNING!
The tray can hold a maximum of 5kg.
WARNING!
Do not step on the mobile stand or parts of it.
To stop the mobile stand in the desired position, lock the wheel brakes by pressing the lever down. Upwards to
unlock.
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2.2. TYPE OF X-RAY HEAD
The mechanical fitting with which the x-ray head is connected to the pantograph arm is an arch. The arch allows the
x-ray head to maintain the position set by the operator.
The generator is can freely rotate both on the horizontal and vertical plane. The rotation is limited by suitable
mechanical stops.
2.3. HANDHELD
The handheld is turned on by pressing any key, except for the one for x-ray emission.
WIRED HANDHELD
This handheld uses a cable connection to communicate with the x-ray unit.
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3. SWITCHING ON AND OFF THE X-RAY DEVICE
The control unit is turned on and off from the main switch
(A).
The switch lights up to indicate that the control unit is
powered.
The control unit is turned on and off from the main switch
(A).
The switch lights up to indicate that the control unit is
powered.
NOTE: The technical specifications of the switch are outlined in paragraph 1.5.
Whenever turned on, the equipment performs an operational test that takes a few seconds. A beep is
emitted at the end of the test.
NOTE: The exposure time and the parameters displayed on the handheld when the unit is turned on are the
last ones set before the control unit was turned off.
If the control unit is left untouched for a few minutes, it will go into standby mode. Simply press any key on
the control panel to reactivate it.
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4. HANDHELD FUNCTIONS
The handheld is turned on by pressing any key, except for the one for x-ray emission.
A buzzer rings to confirm that the unit has been turned on. The unit will be in the standard configuration and it will
start searching for the base it works with.
If the base is off, the handheld will not indicate the field or the status “ready”. If the base is later turned on, the
handheld will detect it within thirty seconds or by pressing any function key on the push-button panel.
NOTE: To optimise the range of the handheld while it is being used, keep it away from walls and metal
instruments and, above all, do not cover its built-in antenna on top of the screen. In addition, performance
may be reduced if the handheld is moved too quickly while x-rays are being taken. Error E 31 may be
displayed if out of range problems occur.
WIRED HANDHELD
NOTE: This section applies only to models RX DC REF: CAEU***C*
(Character * can be any alphanumeric value)
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4.1. HANDHELD DISPLAY FUNCTIONS
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4.2. USE OF HANDHELD
As illustrated in the figure below, the handheld has four function keys and a single x-ray emission key.
Increases the exposure times in steps Increases the scroll speed of the values in
according to the set scale. increasing order.
Decreases the exposure times in steps Increases the scroll speed of the values in
according to the set scale. decreasing order.
NO EFFECTS ARE OBTAINED IF THE KEY Starts x-ray exposure (the button has to be held
IS PRESSED FOR LESS THAN A SECOND. down throughout the x-rays emission, “dead
man” function).
NOTE: “Dead man” function: the system that starts x-ray exposure with the dedicated key on the wireless
handheld allows x-rays to be emitted only when the user presses and holds down the exposure key. X-ray
emission will stop if the key is released ahead of time.
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NOTE: The function related to pressing the key briefly is performed by pressing the key which will activate
the function assigned to it. On the other hand, to perform the function carried out when the key is held down
longer, press the key until the relative function is started. The buzzer will beep shortly to signal that the
function has been activated.
NOTE: Warm-up: When the equipment has not been used for a prolonged period (more than 3 months) or
when turned on for the first time, it is advisable to perform a series of emissions with short times (0.01-0.02
sec.) and then, progressively, some pictures with 0.1 sec. intervals to better stabilise the operation of the x-
ray tube before using it.
Before actually taking an exposure, make sure the exposure parameters for the examination in progress are correctly
set:
- Controlling the type of collimator selected.
Make sure the cone icon shown on the handheld matches the desired cone:
ICON ON: indicates that the x-ray unit is using the built in round cone (diameter 60mm, focal spot-skin
distance 20cm).
ICON OFF: indicates that the external removable rectangular or round cone is attached to the x-ray device
(source-skin distance 30cm).
Refer to paragraph 5.3 to set the type of movable collimator used.
NOTE: After the rectangular collimator (12”) has been attached or detached, the icon and set exposure
times will automatically be modified within a few seconds.
NOTE: After the change has been made, the preset exposure times will automatically be modified.
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- Checking the selected type of intraoral exam.
Upper incisors
Lower molars
or front ”bitewing”
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5. USE OF THE X-RAY DEVICE
A positioner or alignment device specific for the selected image receiver should always be used to assure the x-rays
are correctly aligned regardless of the position the patient’s head is in.
Position the x-ray head so that the cone is aligned with the image receiver.
ARCH TECHNOLOGY
In the versions equipped with arch technology, the x-ray head can freely rotate on
both its horizontal and vertical axis.
Simply moving the x-ray head allows positioning it at the desired angle to perform
the exposure.
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5.3. POSITION OF THE X-RAY PLATE OR SENSOR
The parallel technique, where applicable, provides more accurate images in terms of size compared to the bisecting
technique. A rectangular collimator, with 30 cm (12"), focus-skin distance, is always preferable to obtain better quality
pictures. To avoid exposing the image receiver only partly (whether it is a sensor or photostimulable phosphorus
plate system) an alignment device that gives rectangular collimators guidelines should be used. These lines are
usually given on the alignment ring.
- Parallel technique.
1 Incisors
2 Canines
3 Premolars
4 Molars
5 Upper arch
6 Lower arch
20 OPERATOR'S MANUAL EN
- The x ray emission axis is perpendicular to the image receiver (for example a sensor or photostimulated
phosphor plate) which in turn is parallel with the tooth’s long axis.
- As a result, the picture of the tooth will only be deformed by the divergence of the x rays in relation to the focus
spot.
- Radiographic enlargement may reach up to 15%.
- For some “special” pictures, for example occluded ones, it may be necessary to remove the rectangular
collimator and use the round one if a positioner is not present.
The exposure parameters are set by following the directions given below:
1) Select the tooth to be examined
2) Select the patient size
NOTE: Each tooth and patient size selected is displayed for approximately 1 second according to the
operating mode used (En60, En63 o En65).
The suggested exposure time can be changed with keys and . Exposure times ranging from 0.01s to
1.00s belonging to the R’20 scale can be set. Random exposure times different from the ones provided in the R’20
When the exposure time displayed differs from the default setting, icon comes on.
To save the new setting, make sure that icon is on and then press and hold down key for approximately 2
seconds. The handheld will beep shortly to confirm that the setting has been saved. At this point, make sure that icon
is off.
NOTE: If the exposure time is not saved, the change made will be lost after a new entry or as soon as the
handheld changes over to stand-by.
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WARNING:
After customised settings have been made, the “Original exposure values charts” are no longer valid.
If icon is displayed while the exposure time is changed, it means that the set time cannot be saved for the
selected tooth-patient size combination. In any case, the x-rays can be taken with the set time.
WARNING:
When the suggested exposure time is changed, the sensitivity factor is also modified (by default set to
F=19). Once this change has been saved, it is applied to all the teeth and both patient sizes.
The exposure time can also be modified by changing the sensitivity factor. To do so, press keys and at
Use keys and to change the value from 3 to 25. If the displayed value differs from the previous setting,
icon comes on. To quit this mode, press key or . The change made to the sensitivity factor is applied
22 OPERATOR'S MANUAL EN
5.5. PROCEDURE TO BE FOLLOWED WHEN TAKING THE X-RAY
- Pick up the handheld and move to a safe distance (at least 2 meters) maintaining visual contact with the patient
and x-ray unit during the exposure. Make sure “ready” is indicated.
NOTE: If the “EMIT X-RAY” key is released at any time, exposure will be interrupted and error code E01 will
appear on the display.
- Once exposure has been completed, it is possible to proceed with the next exposure unless the x-ray unit has
reached the maximum allowable temperature. The percentage the cone exceeds the maximum allowable
temperature is always shown on the screen (see icon below).
- Once the temperature has been reached, wait the pause time for cooling signaled by symbol .
- At this point the exposure function will be disabled until the screen shows “ready” again
- As soon as “READY” appears on the handheld, another exposure can be taken.
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6. ADVANCED OPTIONS
The handheld allows the user to view, edit and set some operating parameters by simply combining the keys
provided. Follow the steps outlined below to access:
KEY COMBINATION DESCRIPTION OF COMMAND
Press these two keys to adjust the sensitivity levels (determined based on the table
given below and type of sensor/receiver used), modifying the current value from
the minimum to the maximum allowable one (on a scale from 3 to 25), with keys “+”
and “-”. Press key “size” to confirm the desired level and go back to the main
+ screen.
Hold down these two keys to go to the set-up menu (from P 01 to P 07).
Press key “size” to make the selection. Once within the individual configurations,
they can be scrolled with keys “+” and “-” and selected by pressing key “size”
again. Key "tooth" quits the configuration without saving the setting.
The configurations are outlined in detail below:
- P 01: Sets the stand-by time (from a minimum of 5 to a maximum of 30
minutes).
- P 02: Assigns an identification tag to the x-ray unit base (from 1 to 5 or none).
- P 03: Shows the list of software versions.
+ - P 04: Handheld unique code display.
- P 05: Activates/deactivates the safety unlock mode (only with ball joint).
- P 06: Operating mode.
- P 07: Sets the type of removable collimator used.
- P 08: Set current value (only for 70kV x-ray heads).
24 OPERATOR'S MANUAL EN
6.1. SETTING THE OPERATING MODE
For both operating modes, the exposure time is in the range 0.02s - 1s. The permitted anode voltage and current
combinations are shown in the following table:
NOTE: This section applies only to models RX DC REF: CAEU*6***
(Character * can be any alphanumeric value)
Table 1
60-7 60 kV 7 mA
63-6 63 kV 6 mA
65-6 65 kV 6 mA
Table 2
60-8 60 kV 8 mA
65-8 65 kV 8 mA
70-8 70 kV 8 mA
60-4 60 kV 4 mA
65-4 65 kV 4 mA
70-4 70 kV 4 mA
To set the operative mode, press keys and to go to the setup menu.
Scroll the parameters up to parameter P06 and press key . Scroll the options to find the desired operating mode
EN OPERATOR'S MANUAL 25
6.2. SETTING TYPE OF MOVABLE COLLIMATOR
NOTE: For an ideal use of the x-ray unit, set the collimator depending on the type used.
To set the type of collimator, press keys and to go to the set-up menu.
Scroll the parameters up to parameter P07 and press key . Scroll the options to find the type of collimator used
To restore the factory settings (see paragraph 4.4) press keys and to go to the set-up menu.
Press keys and simultaneously. “rESS” will briefly appear and the handheld will be rebooted.
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7. ERROR MESSAGES
E34 INTERLOCK ERROR Close the door and if necessary repeat the test.
NOTE: As regards the other error codes, CONTACT the technical service department.
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8. PERIODIC MAINTENANCE
WARNING:
Any technical maintenance work required must be carried out by qualified personnel or by a specialised
technician authorised by the manufacturer. It is the user’s responsibility to check that an authorised
technician carries out routine maintenance at least every year. The maintenance methods are specified in
the Technical Service Manual possessed by the Authorised Technicians
For safety reasons and for the health of the patient, operator and third-parts inspections and maintenance must be
carried out at regular intervals.
Quality control by means of a dental phantom for image acquiring systems, according to IEC 61223-3-4:2000:
The quality control consists in performing a radiological investigation by means of the tested device and the
acquisition system Zen-X or X-Pod. The sensitivity of the x-ray unit must be set according to what is stated in
paragraph 14.
Alternatively, you can verify that the measured load factors (kV, mA, ms) fall within the accuracy limits stated in
Section 11.
Periodic monitoring ensures the proper functioning of the device and the conformity of the results obtained.
28 OPERATOR'S MANUAL EN
9. CLEANING AND DISINFECTION
- Cleaning is the first necessary step for any disinfection process. Rubbing with detergents and
surfactants and rinsing with water removes allows removing a considerable number of microorganisms.
If a surface is not cleaned first, the disinfection process cannot be successful.
- The recommended products have been tested: they are technically compatible with the device
materials.
- Damages to surfaces and materials due to the use of different products cannot be excluded even if they
are not included in the exceptions mentioned above.
EN OPERATOR'S MANUAL 29
10. DISPOSING THE EQUIPMENT WHEN NO LONGER USED
WARNING!
Never remove the device covers.
The device does not contain parts that can be repaired directly by the user. In the event of malfunctioning, do not
attempt to carry out any type of maintenance operation. If you find or suspect any kind of system malfunctioning, do
not attempt to carry out any type of maintenance operation and do not use the system on a patient, but directly
contact your local distributor.
The user may not carry out maintenance on any mechanical or electronic part of the x-ray system.
Opening the cases to access the internal circuits may cause device breakage and failure of the electrical safety
devices and will lead to forfeiture of the warranty.
Any maintenance, repairs and modifications of the device must be carried out only by personnel directly authorised
by the manufacturer or by third parties expressly authorised by the manufacturer and must be carried out according
to the laws in force and the generally accepted technical standards.
All the system components must be checked and replaced, if necessary, by qualified personnel.
For any maintenance operation, please contact the manufacturer via the website indicated on the cover of this
manual by filling in the Information Request form.
Should you for any reason need to return the device or its parts to the manufacturer or a Technical Service centre,
disinfect all the external parts of the device using a specific product (see the paragraph “Cleaning and disinfection”)
and preferably return it in its original packaging.
At the end of its lifetime, dispose of the device in accordance with the regulations in force. It is also advisable to
disinfect all the external parts of the device before disposal and to separate the materials for differentiated waste
collection.
In accordance with Directives 2002/95/EC, 2002/96/EC and 2003/108/EC regarding reduced use of dangerous
substances in electrical and electronic devices as well as waste disposal, do not dispose of the devices in the
household waste but collect them separately.
When purchasing a new device of an equivalent type, one for one, the device that has come to the end of its lifetime
should be returned to the dealer for disposal.
As regards reuse, recycling and other forms of recovery of the above mentioned waste, the manufacturer carries out
the functions defined in the individual national legislations.
Appropriate differentiated waste collection for subsequent recycling treatment and environmentally friendly disposal
contributes to preventing possible negative effects on the environment and health and encourages recycling of the
materials of which the device is made up.
The crossed-out bin symbol on the device indicates that the product must be collected separately from other waste at
the end of its useful life.
WARNING!
Abusive disposal of the product is liable to a fine as laid down in the individual national legislations.
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11. TECHNICAL DATA
.WEIGHTS
- Weight of the unit with packaging: 38Kg (84lb) max.
- Weight of the x-ray unit: 25Kg (55 lb).
- Weight of the handheld: 0.3Kg (0.7 lb).
- Weight of the x-ray mobile stand: 20Kg (44 lb).
EN OPERATOR'S MANUAL 31
NOTE: This section applies only to models RX DC REF: CAEU*6***
(Character * can be any alphanumeric value)
WEIGHTS
- Weight of the unit with packaging: 38Kg (84lb) max.
- Weight of the x-ray unit: 25Kg (55 lb).
- Weight of the handheld: 0.3Kg (0.7 lb).
- Weight of the x-ray mobile stand: 20Kg (44 lb).
32 OPERATOR'S MANUAL EN
11.1. X-RAY TUBES
EN OPERATOR'S MANUAL 33
X-RAY TUBE TOSHIBA D-0711, Kailong KL21-0,7.
- Anode inclination: 16.0°
- Anode thermal load: 7.0 KJ
- Maximum continuous heat dissipation: 170 W.
- Operating cycle: 1:60 (1 second exposure - 60
seconds pause time).
34 OPERATOR'S MANUAL EN
12. DIMENSIONAL CHARACTERISTICS
EN OPERATOR'S MANUAL 35
36 OPERATOR'S MANUAL EN
MOBILE STAND VERSION
EN OPERATOR'S MANUAL 37
38 OPERATOR'S MANUAL EN
13. IDENTIFICATION PLATES
WARNING:
Never remove the identification nameplates provided on the generator, control unit and collimator cone.
X-ray head.
The nameplate is located on the lower cover at the back of
the x-ray head.
Data given on plate:
- Name of manufacturer.
- Name of equipment.
- Technical specifications.
- Model and x-ray tube serial number.
- Equipment serial number.
- Month and year of manufacture.
- Symbol required by standards.
EN OPERATOR'S MANUAL 39
Collimator.
The nameplate for the rectangular collimator is found
outside it.
Data given on plate:
- Name and address of the manufacturer.
- Equipment code.
- Technical data.
- DHHS compliance.
- Serial number.
- Month and year of manufacture.
Wired handheld.
The handheld control plate is located at the centre on the
back.
Plate images are purely illustrative; refer to the plate placed on the device.
40 OPERATOR'S MANUAL EN
14. TIMES/SENSITIVITY CHARTS
When using the x-ray unit, in conjunction with Zen-X or X-Pod, it is recommended to use the default value of
sensitivity.
When using the x-ray unit, in conjunction with digital sensors (CMOS / CCD), phosphors or films, you need to find the
appropriate exposure time in relation to the image that you want to obtain. Once identified this time for a specific
combination of tooth and patient size, you can set the sensitivity parameter in accordance with the exposure time
found (procedure described in paragraph 5.4).
Sensitivity 19*
Collimator (focus-skin distance) 20 cm (8") 30 cm (12")
Mode En60 En63 En65 En60 En63 En65
Patient size A B A B A B A B A B A B
Lower incisors 0.125 0.080 0.110 0.071 0.100 0.063 0.250 0.160 0.220 0.140 0.200 0.125
Lower canines/bicuspids 0.160 0.100 0.140 0.090 0.125 0.080 0.320 0.200 0.280 0.180 0.250 0.160
Upper incisors/front “bitewing” 0.160 0.100 0.140 0.090 0.125 0.080 0.320 0.200 0.280 0.180 0.250 0.160
Lower molars 0.200 0.125 0.180 0.110 0.160 0.100 0.400 0.250 0.360 0.220 0.320 0.200
Upper canines/bicuspids/rear “bitewing” 0.200 0.125 0.180 0.110 0.160 0.100 0.400 0.250 0.360 0.220 0.320 0.200
Upper molars 0.250 0.160 0.220 0.140 0.200 0.125 0.500 0.320 0.450 0.280 0.400 0.250
Sensitivity 19*
Collimator (focus-skin distance) 20 cm (8") 30 cm (12")
Mode En60 En65 En70 En60 En65 En70
Patient size A B A B A B A B A B A B
Lower incisors 0.110 0.071 0.080 0.050 0.063 0.040 0.220 0.140 0.160 0.100 0.140 0.080
Lower canines/bicuspids 0.140 0.090 0.100 0.063 0.080 0.056 0.280 0.180 0.200 0.125 0.160 0.110
Upper incisors/front “bitewing” 0.140 0.090 0.100 0.063 0.080 0.056 0.280 0.180 0.200 0.125 0.160 0.110
Lower molars 0.180 0.110 0.125 0.080 0.110 0.063 0.360 0.220 0.250 0.160 0.220 0.140
Upper canines/bicuspids/rear “bitewing” 0.180 0.110 0.125 0.080 0.110 0.063 0.360 0.220 0.250 0.160 0.220 0.140
Upper molars 0.220 0.140 0.160 0.100 0.140 0.080 0.450 0.280 0.320 0.200 0.280 0.160
* = Default settings
A = Adult
B= Child
EN OPERATOR'S MANUAL 41
15. NOMINAL DOSE EMISSION VALUES
42 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)
EN OPERATOR'S MANUAL 43
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)
44 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)
EN OPERATOR'S MANUAL 45
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)
Collimator Round ø 55 mm
SSD 30 cm
A (cm2) 23.75
KV - mA 60kV 7mA 63kV 6mA 65kV 6mA
t (s) DOSE DAP DOSE DAP DOSE DAP
mGy mGy · cm2 mGy mGy · cm2 mGy mGy · cm2
0.020 0.09 2.0 0.08 1.9 0.08 2.0
0.022 0.09 2.2 0.09 2.1 0.09 2.2
0.025 0.11 2.5 0.10 2.4 0.11 2.5
0.028 0.12 2.8 0.11 2.7 0.12 2.8
0.032 0.14 3.2 0.13 3.0 0.14 3.2
0.036 0.15 3.7 0.14 3.4 0.15 3.6
0.040 0.17 4.1 0.16 3.8 0.17 4.0
0.045 0.19 4.6 0.18 4.3 0.19 4.5
0.050 0.21 5.1 0.20 4.7 0.21 5.0
0.056 0.24 5.7 0.22 5.3 0.24 5.6
0.063 0.27 6.4 0.25 6.0 0.27 6.3
0.071 0.30 7.2 0.28 6.7 0.30 7.1
0.080 0.34 8.1 0.32 7.6 0.34 8.0
0.090 0.38 9.1 0.36 8.5 0.38 9.0
0.100 0.43 10.1 0.40 9.5 0.42 10.0
0.110 0.47 11.2 0.44 10.4 0.47 11.1
0.125 0.53 12.7 0.50 11.8 0.53 12.6
0.140 0.60 14.2 0.56 13.3 0.59 14.1
0.160 0.68 16.2 0.64 15.2 0.68 16.1
0.180 0.77 18.3 0.72 17.1 0.76 18.1
0.200 0.85 20.3 0.80 19.0 0.85 20.1
0.220 0.94 22.3 0.88 20.8 0.93 22.1
0.250 1.07 25.4 1.00 23.7 1.06 25.1
0.280 1.20 28.4 1.12 26.5 1.18 28.1
0.320 1.37 32.5 1.28 30.3 1.35 32.1
0.360 1.54 36.5 1.44 34.1 1.52 36.2
0.400 1.71 40.6 1.60 37.9 1.69 40.2
0.450 1.92 45.6 1.80 42.6 1.90 45.2
0.500 2.14 50.7 2.00 47.4 2.12 50.2
0.560 2.39 56.8 2.23 53.1 2.37 56.3
0.630 2.69 63.9 2.51 59.7 2.66 63.3
0.710 3.03 72.0 2.83 67.3 3.00 71.3
0.800 3.42 81.1 3.19 75.8 3.38 80.4
0.900 3.84 91.3 3.59 85.3 3.81 90.4
1.000 4.27 101.4 3.99 94.8 4.23 100.5
46 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)
Collimator Round ø 55 mm
SSD 30 cm
A (cm2) 23.75
KV - mA 60kV 8mA 65kV 8mA 70kV 8mA
t (s) DOSE DAP DOSE DAP DOSE DAP
mGy mGy · cm2 mGy mGy · cm2 mGy mGy · cm2
0.020 0.10 2.3 0.11 2.7 0.13 3.0
0.022 0.11 2.5 0.12 2.9 0.14 3.3
0.025 0.12 2.9 0.14 3.3 0.16 3.8
0.028 0.14 3.2 0.16 3.8 0.18 4.2
0.032 0.16 3.7 0.18 4.3 0.20 4.8
0.036 0.18 4.2 0.20 4.8 0.23 5.4
0.040 0.20 4.6 0.23 5.4 0.25 6.0
0.045 0.22 5.2 0.25 6.0 0.29 6.8
0.050 0.24 5.8 0.28 6.7 0.32 7.6
0.056 0.27 6.5 0.32 7.5 0.36 8.5
0.063 0.31 7.3 0.36 8.4 0.40 9.5
0.071 0.35 8.2 0.40 9.5 0.45 10.7
0.080 0.39 9.3 0.45 10.7 0.51 12.1
0.090 0.44 10.4 0.51 12.1 0.57 13.6
0.100 0.49 11.6 0.56 13.4 0.64 15.1
0.110 0.54 12.7 0.62 14.7 0.70 16.6
0.125 0.61 14.5 0.71 16.7 0.80 18.9
0.140 0.68 16.2 0.79 18.8 0.89 21.1
0.160 0.78 18.5 0.90 21.4 1.02 24.2
0.180 0.88 20.9 1.02 24.1 1.14 27.2
0.200 0.98 23.2 1.13 26.8 1.27 30.2
0.220 1.07 25.5 1.24 29.5 1.40 33.2
0.250 1.22 29.0 1.41 33.5 1.59 37.8
0.280 1.37 32.5 1.58 37.5 1.78 42.3
0.320 1.56 37.1 1.80 42.9 2.04 48.3
0.360 1.76 41.7 2.03 48.2 2.29 54.4
0.400 1.95 46.4 2.26 53.6 2.54 60.4
0.450 2.20 52.2 2.54 60.3 2.86 68.0
0.500 2.44 58.0 2.82 67.0 3.18 75.5
0.560 2.73 64.9 3.16 75.0 3.56 84.6
0.630 3.07 73.0 3.55 84.4 4.01 95.2
0.710 3.46 82.3 4.00 95.1 4.52 107.2
0.800 3.90 92.7 4.51 107.2 5.09 120.8
0.900 4.39 104.3 5.08 120.6 5.72 135.9
1.000 4.88 115.9 5.64 134.0 6.36 151.1
EN OPERATOR'S MANUAL 47
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)
48 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)
EN OPERATOR'S MANUAL 49
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)
50 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)
An indirect measure of the DAP can be obtained by a measuring instrument of the absorbed dose.
In this case, the DAP is obtained by multiplying the dose measurement for the irradiated area.
The data obtained by this measurement has a tolerance of not less than 20%.
EN OPERATOR'S MANUAL 51
16. INSPECTION AND MAINTENANCE
16.1. USER INSPECTION
These instructions describe the maintenance procedures for the x-ray unit.
These instructions apply to all versions of said equipment, as well as all the accessories that may have been provided, therefore the description of some parts may not correspond to your equipment.
Inspection and preventive maintenance must be performed at scheduled intervals to protect the health and safety of patients, users and other persons in accordance with national regulations regarding the use and maintenance of dental x-ray
units that are in force in the country where the device is installed.
In order to ensure the operational safety and functional reliability of your product, the system owner should check the equipment at regular intervals (at least once a year) or commission an authorised technician to do so.
If one or more checks to be performed are not satisfactory, please contact your dealer for technical support.
4 Check the remote control functionality: buttons must respond to interaction Section Control Panel
Check the power switch verifying that the switch is working properly and the
5 Section Turning the x-ray unit on and off
main switch green light switches on when the switch is in the ON position.
Check the electromechanical brake that lock/unlock the movement of the
6 Section Ball joint technology
generator – ball joint model units only
Check proper functioning of x-ray generator indicator light – ball joint model units
7 Section X-ray generator indicator light
only
8 Check the exposure buzzer during a trial x-rays emission Section Performing the exposure
9 Verify that exposure is immediately interrupted when x-ray button is released Section Performing the exposure
10 Check the scissors arm balance Section Description of the x-ray unit
11 Verify that exposure is immediately interrupted when x-ray button is released Section Performing the exposure
Check the x-ray generator functionality performing a complete trial exposure.
Select any exposure time and hold down the emission button throughout the
12 Section Using the x-ray unit
entire exam procedure. Absence of error messages assures proper generator
functionality.
Operator Name
Signature
The undersigned confirms that the equipment was checked for the above criteria and that, in case of any malfunction, an authorised technician of the local dealer was informed.
All inspection and maintenance work performed by the system owner and/or service engineer must be recorded in this document and kept near the unit!
52 OPERATOR'S MANUAL EN
16.2. TECHNICAL MAINTENANCE
These instructions describe the maintenance procedures for the x-ray unit. These instructions apply to all versions of said equipment.
In order to ensure the operational safety and functional reliability of the equipment installed, at least once a year an authorised service technician must perform a full inspection of the device.
When taking measurements that require a multimeter, always use a calibrated digital multimeter.
All the following tests will be carried out. Customer should be notified prior to replacing any parts.
7 Check the remote control functionality: buttons must respond to interaction User Manual, Section Control Panel
Check the power switch verifying that the switch is working properly and the
8 Section Turning the x-ray unit on and off
main switch green light switches on when the switch is in the ON position.
Check proper functioning of x-ray generator indicator light – ball joint model
9 User Manual, Section X-ray generator indicator light
units only
10 Check the exposure buzzer during a trial x-rays emission User Manual, Section Performing the exposure
11 Verify that exposure is immediately interrupted when x-ray button is released Section Performing the exposure
12 Check the scissors arm balance and adjust it if necessary Technical Manual, Section Balancing the double pantograph arm
13 Perform a calibration of the x-ray tube housing Technical Manual, Section Calibrating the x-ray head
Operator Name
Signature
The undersigned confirms that the equipment was checked for the above criteria and that it was provided in optimal operating conditions.
All inspection and maintenance work performed by the system owner and/or service engineer must be recorded in this document and kept near the unit!
EN OPERATOR'S MANUAL 53