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RX-DC Hyper. Operating Manual

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0% found this document useful (0 votes)
20 views

RX-DC Hyper. Operating Manual

Uploaded by

Georges Kayal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 62

97050901

REF 97050900
Rev. 03
2018-11

RX DC

EN
2 OPERATOR'S MANUAL EN
ITALIANO
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
1.8. ELECTROMAGNETIC SAFETY ........................................................................................................................... 9
2. DESCRIPTION OF THE X-RAY DEVICE ............................................................................................................... 12
2.1. INSTALLATION TYPE ........................................................................................................................................ 12
2.2. TYPE OF X-RAY HEAD ..................................................................................................................................... 15
2.3. HANDHELD ........................................................................................................................................................ 16
3. SWITCHING ON AND OFF THE X-RAY DEVICE .................................................................................................. 17
4. HANDHELD FUNCTIONS ....................................................................................................................................... 18
4.1. HANDHELD DISPLAY FUNCTIONS.................................................................................................................. 19
4.2. USE OF HANDHELD ......................................................................................................................................... 20
4.3. CHECKING THE PARAMETERS....................................................................................................................... 21
4.4. FACTORY SETTINGS ....................................................................................................................................... 22
5. USE OF THE X-RAY DEVICE................................................................................................................................. 23
5.1. PATIENT POSITIONING .................................................................................................................................... 23
5.2. POSITIONING THE X-RAY HEAD ..................................................................................................................... 23
5.3. POSITION OF THE X-RAY PLATE OR SENSOR ............................................................................................. 24
5.4. SETTING THE EXPOSURE MODE AND TIME ................................................................................................. 25
5.5. PROCEDURE TO BE FOLLOWED WHEN TAKING THE X-RAY ..................................................................... 27
6. ADVANCED OPTIONS ........................................................................................................................................... 28
6.1. SETTING THE OPERATING MODE .................................................................................................................. 29
6.2. SETTING TYPE OF MOVABLE COLLIMATOR ................................................................................................. 30
6.3. RESTORING FACTORY SETTINGS ................................................................................................................. 30
7. ERROR MESSAGES .............................................................................................................................................. 31
8. PERIODIC MAINTENANCE .................................................................................................................................... 34
9. CLEANING AND DISINFECTION ........................................................................................................................... 35
10. DISPOSING THE EQUIPMENT WHEN NO LONGER USED ................................................................................ 36
11. TECHNICAL DATA .................................................................................................................................................. 37
11.1. X-RAY TUBES ............................................................................................................................................... 39
11.2. TECHNICAL FACTOR MEASURE ................................................................................................................ 40
12. DIMENSIONAL CHARACTERISTICS ..................................................................................................................... 41
13. IDENTIFICATION PLATES ..................................................................................................................................... 48
14. TIMES/SENSITIVITY CHARTS ............................................................................................................................... 50
15. NOMINAL DOSE EMISSION VALUES ................................................................................................................... 51
16. INSPECTION AND MAINTENANCE ....................................................................................................................... 61
16.1. USER INSPECTION ...................................................................................................................................... 61
16.2. TECHNICAL MAINTENANCE ........................................................................................................................ 62

EN OPERATOR'S MANUAL 3
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.

The contents of this publication are valuable trade secrets and must not be given to third parties, stored, copied,
reproduced, disclosed or transferred in any manner (via computer, 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; this is a translation from the original in Italian.
The Manufacturer’s website contains a list of authorised agents.

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.

Protective ground contact.

Alternating current.

On.

Off.

Ionising radiations.

Equipment compliant with directive 93/42/EEC as amended.

Disposal symbol in accordance with Directive 2012/19/EU.

FCC ID F.C.C. mark (Federal Communication Commission).

Operating instructions. Consult the enclosed documentation before using the device.

EN OPERATOR'S MANUAL 5
It is necessary to refer to the user manual.

Pushing prohibited.

Stepping prohibited.

Ukrainian national symbol of conformity.


UA.TR.101

REF - TYPE Product/equipment identification code.

Product serial number.

Manufacturer.

Date of manufacture.

1.2. STANDARDS AND REGULATIONS

The system has been designed to meet the following Directives:


- Directive 93/42/EEC and s.c.(dir. 2007/47/EC) - Medical Device Directive;

Technical Standards:
IEC 60601-1:2005
IEC 60601-1-2:2014
IEC 60601-1-3:2008
IEC 60601-2-65:2012
IEC 60601-1-6:2010
IEC 62366:2007

The CE marking certifies compliance of the product as described by Medical Device Directive 93/42/EEC and
subsequent amendments.

1.3. INTENDED USE

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

- Classification of MEDICAL DEVICES.


Classification of the equipment according to the rules indicated in Annex IX of Directive 93/42/EEC and subsequent
changes: CLASS IIB.
- ELECTRO-MEDICAL EQUIPMENT classification.
Equipment classification in accordance with standard I.E.C. 60601-1 for safety of medical equipment: CLASS I
TYPE B, not continuous use.
- EMC classification.
Classification of the equipment in accordance with standard IEC 60601-1-2 Group 1, Class A (CISPR 11).

6 OPERATOR'S MANUAL EN
1.5. ENVIRONMENTAL CONDITIONS

The equipment is to be installed in rooms that satisfy the following requirements:


- Temperature from +10°C to +40° C.
- Relative humidity from 25 to 75% without condensate.
- Atmospheric pressure from 700 to 1060 hPa.
- The electrical wiring in the room in which the equipment is installed must conform to I.E.C. 60364-7-710;V2
specification (i.e. the regulations concerning the electrical wiring to be used in surgeries) or equivalent standards
in force in the country where the equipment is installed.
- ELECTRICAL CONNECTIONS: the electrical system must be provided with an adequate grounding system that
complies with regulations I.E.C. - US National Electrical Code and C.E.I.. In Italy, it must be executed in accordance
with IEC 60364-7-710, which requires a differential-thermal breaker with the following characteristics upstream of
the system:
- contact capacity: 250V 10A or 120V 16A in compliance with standards IEC 60898-1 and IEC 60947-2;
- differential sensitivity: 0.03A;
- power supply: 3x2.5 mm2.
The colour of the 3 wires should be as specified in the standards (BROWN power, BLUE neutral, YELLOW/GREEN
ground).

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.
- Do not open the device covers: installation, repairs and in general all the operations that require opening the device
must be carried out exclusively by technicians authorised by the Manufacturer.
- 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 in the dental surgery or nearby of electric scalpels or other electric devices that do not comply with
standard I.E.C. 60601-1-2 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 (under civil and criminal law) 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.

EN OPERATOR'S MANUAL 7
1.7. PROTECTION AGAINST RADIATION

PROTECTION AGAINST RADIATIONS.


X-rays are hazardous and adequate precautions must be taken when using them. Areas where it is possible
to be exposed to x-rays shall be clearly indicated by using this symbol, which should remind personnel to
observe the safety rules laid down by the laws in force in the country where the equipment is used.
- Control the emission of x-rays from the greatest distance possible (at least 2 meters) from the focal spot
and the x-ray irradiation beam in the opposite direction to where the rays are emitted. For installations in
Canada, the required distance is 3 metres.
- Only the authorised personnel and the patient can remain in the room when x-rays are being emitted.
- The device is provided with an interlock input. If the interlock is activated, it means that the door is open
while the examination is in progress and the ray emission is inhibited. To proceed with the examination,
close the door.
- Make sure that the operator can communicate verbally and visually with the patient during the
examination.
- As for the installation, please refer to the Technical Manual.
- Always protect the patient’s thyroid and gonads under all circumstances.
- Whenever the patient is a child or disabled person requiring the presence of the dentist to keep the image
receiver in position, it is advisable to use a positioner, following the instructions of the Manufacturer of the
receiver, and a special glove to protect the hand against x-rays. Use a suitable overall to protect the rest
of the body against exposure to x-rays.

8 OPERATOR'S MANUAL EN
1.8. ELECTROMAGNETIC SAFETY
The device is intended for use in environments recognised as professional health facilities, as described in IEC 60601-
1-2:2014. The device belongs to CISPR 11 Class A Group 1 and complies with immunity test levels specified by IEC
60601-1-2:2014 for professional health facilities.
Before using any electronic device in health facilities, always check that it is compatible with the other equipment
present.
Even if the device complies with standard IEC 60601-1-2, it is recommended not to use it near life-support
equipment (e.g.: pacemakers or cardiac stimulators). For further information, see the equipment instructions
for use.

Use of this equipment adjacent to or stacked with other equipment should be avoided, because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed
to verify that they are operating normally.

Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Do not subject the device to strong electromagnetic disturbances. These disturbances could degrade the
essential performance of the device.

The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the equipment.

EN OPERATOR'S MANUAL 9
Guidance and Manufacturer's declaration - Electromagnetic emissions
RX DC is designed to operate in the specified electromagnetic environment. The customer or the user of RX DC
must ensure its use in an electromagnetic environment with the following features:
Emission test Conformity Electromagnetic Environment
RX DC uses RF energy only for its internal operation.
RF emissions
Group 1 For this, the RF emissions are very low and do not
CISPR 11
interfere with the electronic devices nearby.
RX DC must be used only by adequately trained
personnel (dentists and paramedics). RX DC may
cause radio interferences or disturb the operation of
RF emissions
Class A the nearby equipment. It may be necessary to adopt
CISPR 11
countermeasures, such as re-orienting or moving RX
DC or shielding the installation site.

Guidance and Manufacturer's declaration - Electromagnetic immunity


RX DC is designed to operate in the specified electromagnetic environment. The customer or the user of RX DC
must ensure its use in an electromagnetic environment with the following features:
Immunity test IEC 60601-1-2 Level of Electromagnetic Environment
Test level conformity
Floors must be made of wood, concrete or
Electrostatic
± 8 kV contact IEC 60601-1-2 ceramic tiles. If floors are covered with
discharge (ESD)
± 15 kV air Test level synthetic material, the relative humidity
IEC 61000-4-2
should be at least 30%.
± 2 kV for electrical The power supply line quality should be that
IEC 61000-4-4
lines IEC 60601-1-2 of a typical commercial or hospital
fast/burst electric
± 1 kV for input/output Test level environment.
transients
lines > 3 m
± 1 kV differential The power supply line quality should be that
Overvoltage IEC 60601-1-2
mode of a typical commercial or hospital
IEC 61000-4-5 Test level
± 2 kV standard mode environment.
Ut = 0% (at 0°, 45°, The power supply line quality should be that
90°, 135°, 180°, 225°, of a typical commercial or hospital
Voltage drops,
270°, 315°) for 0.5 environment. If the RX DC user requires a
short interruptions
cycles continuous operation also in case of
and voltage IEC 60601-1-2
Ut = 0% per 1 cycle blackout, it is recommended to power the
change on the IEC Test level
Ut = 70% (at 0°) per RX DC with uninterruptible power supply or
61000-4-11 input
25/30 cycles batteries.
electric line
Ut = 0% per 250/300
cycles
Magnetic field at The magnetic fields at network frequency
network frequency IEC 60601-1-2 should feature levels typical of a standard
30 A/m
(50/60 Hz) Test level commercial or hospital environment.
IEC 61000-4-8

10 OPERATOR'S MANUAL EN
Guidance and Manufacturer's declaration - Electromagnetic immunity
RX DC is designed to operate in the specified electromagnetic environment. The customer or user of RX DC must
ensure that it is used in such environment.
Immunity test IEC 60601-1-2 Level of Electromagnetic Environment
Test level conformity
The RF communication devices (portable
and mobile) must not be used at a distance
from RX DC and its components, including
cables, lower than the recommended
distance using the corresponding equation
applicable to the transmitter frequency.
Recommended distance.
3 V/m d = 1.2 x √P 80 MHz to 800MHz
Radiated RF IEC 60601-1-2
From 80 MHz to 2.7 d = 2.3 x √P 800 MHz to 2.7GHz
EN 61000-4-3 Test level
GHz
3V d = 1.2 x √P
from 150 kHz to 80
Conducted RF IEC 60601-1-2
MHz
EN 61000-4-6 Test level
6V
ISM frequencies
Where P is the maximum output power of
the transmitter in Watt (W) according to the
transmitter Manufacturer, and d is the
recommended distance in metres (m).
The field intensity of the fixed RF
transmitters, determined based on an
electromagnetic site, could be lower than
the conformity level in each frequency
interval.
Near the equipment with the following
symbol interferences can be caused:

Recommended distance between the RF portable and mobile communication devices and RX DC.
RX DC is intended for use in electromagnetic environment where RF irradiated disturbances are controlled. The
customer or the user of the RX DC can prevent electromagnetic interferences by ensuring a minimum distance
between RF mobile and portable (transmitter) communication devices and RX DC as shown below, according to
maximum power output of the communication devices.
Distance according the transmitter frequency
Transmitter maximum nominal
(m)
output
150KHz to 80MHz 80KHz to 800MHz 800KHz to 2.7MHz
(W)
d = 1.2 x √P d = 1.2 x √P d = 2.3 x √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters having a maximum nominal output power not listed above, the recommended distance d in metres
(m) can be determined using the corresponding equation applicable to the transmitter frequency where P is the
maximum output power of the transmitter in Watt (W) according to the transmitter Manufacturer.
Note:
(1) At 80MHz and 800MHz it is necessary to apply the distance defined for the highest frequency interval.
(2) These guidelines cannot be applicable to all situations. The electromagnetic propagation is influenced by the
absorption and reflection of structures, objects and people.

EN OPERATOR'S MANUAL 11
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.

2.1. INSTALLATION TYPE

WALL-MOUNTED VERSION

NOTE: This section applies only to models RX DC REF: MRPU****S, MRXU****S


(Character * can be any alphanumeric value)

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 MRPU****S): minimum skin/focus distance 30cm and 45x35
mm output beam (rectangular collimator attached).
- removable 12” round COLLIMATOR (standard for MRXU****S, optional for MRPU****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.

12 OPERATOR'S MANUAL EN
INSTALLATION INTEGRATED IN DENTAL UNIT
NOTE: This section applies only to models RX DC REF: MRPU****I
(Character * can be any alphanumeric value)

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 MRPU****I): minimum skin/focus distance 30cm and 45x35
mm output beam (rectangular collimator attached).
- removable 12” round COLLIMATOR (optional for MRPU****I): 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 only size of the extension arm is 30 cm (11.8”).
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.

NOTE: when integrating the x-ray unit in the dental unit, the integration must be suitable and in line with the
provisions of IEC60601-1. For installation instructions and details, refer to the technical manual.

EN OPERATOR'S MANUAL 13
MOBILE STAND INSTALLATION

NOTE: This section applies only to models RX DC REF: MRXU****M


(Character * can be any alphanumeric value)

WARNING!
Never move the mobile stand x-ray unit without first securing the support arm with the special strap.

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.

NOTE: always lock at least two brakes to avoid unwanted movements.

14 OPERATOR'S MANUAL EN
2.2. TYPE OF X-RAY HEAD

X-RAY HEAD WITH BALL JOINT

NOTE: This section applies only to models RX DC REF: MRPU*****


(Character * can be any alphanumeric value)

The mechanical fitting with which the x-ray head is connected to the pantograph arm is a ball joint. The ball is provided
with a mechanical brake to allow the x-ray head to maintain the position set by the operator.
The generator can freely rotate on the horizontal plane. On the vertical plane, the upward rotation is limited by a
mechanical end stop.

The cone, indicated with *, is the only applied part

X-RAY GENERATOR INDICATOR LIGHT FOR X-RAY UNIT WITH BALL JOINT:

The x-ray generator is provided with an indicator light (B) that signals the unit status.
Key to colours:
- violet > x-ray unit on (regular condition)
- flashing violet > stand-by (low consumption)
- blue > x-ray unit on – head locked
- yellow > x-ray being emitted
- red > fault

X-RAY HEAD WITH ARCH

NOTE: This section applies only to models RX DC REF: MRXU*****


(Character * can be any alphanumeric value)

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.

The cone, indicated with *, is the only applied part

EN OPERATOR'S MANUAL 15
2.3. HANDHELD

The handheld is turned on by pressing any key, except for the one for x-ray emission.

WIRELESS HANDHELD

NOTE: This section applies only to models RX DC REF: MRPU***W*, MRXU***W*


(Character * can be any alphanumeric value)

This handheld uses a wireless connection to communicate with the x-ray unit.
The wireless communication complies with specifications IEEE 802.11 b/g/n. The connection is protected through
cryptography and no other wireless product, except for the handheld, can connect to the unit.
Handheld batteries:
- Type: 2 x AA - Alkaline 1.5V.

The wireless communication can be affected by interferences caused by other equipment such as:
- WiFi routers
- surveillance systems
- Audio/Video repeaters
- cordless phones

With wireless communication interferences proceed as indicated in the technical manual (§10.4).

With a too high level of interferences the handheld cannot guarantee a correct operation and it deactivates the wireless
communication. In these latter cases it is preferable to use a wired handheld.

WIRED HANDHELD

NOTE: This section applies only to models RX DC REF: MRPU***C*, MRXU***C*


(Character * can be any alphanumeric value)

This handheld uses a cable connection to communicate with the x-ray unit.

16 OPERATOR'S MANUAL EN
3. SWITCHING ON AND OFF THE X-RAY DEVICE

TURNING ON THE WALL-MOUNTED X-RAY UNIT

NOTE: This section applies only to models RX DC REF: MRPU****S, MRXU****S


(Character * can be any alphanumeric value)

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.

TURNING ON THE X-RAY UNIT INTEGRATED IN THE DENTAL UNIT

NOTE: This section applies only to models RX DC REF: MRPU****I


(Character * can be any alphanumeric value)

The control unit is automatically turned on and off using the


main switch of the dental unit.
However, the x-ray unit has its own power supply line with
The ON/OFF switch position depends on the type of wall-mounted switch (not provided) to shut off power
integration in the dental unit. For this reason, please refer separately from the dental unit.
to the user manual of the relevant dental units. Make sure that the switch has been turned on when the
device needs to be used.

TURNING ON THE MOBILE STAND X-RAY UNIT

NOTE: This section applies only to models RX DC REF: MRXU****M


(Character * can be any alphanumeric value)

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.

EN OPERATOR'S MANUAL 17
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.

WIRELESS HANDHELD
NOTE: This section applies only to models RX DC REF: MRPU***W*, MRXU***W*
(Character * can be any alphanumeric value)

AUTOMATIC HANDHELD SHUT OFF:


Once the control unit has been turned off, the handheld automatically shuts off after approximately one minute.
The handheld also automatically shuts off when it is at a further distance from the maximum range of the control until.

HANDHELD TIMED STAND-BY:


The entire x-ray unit will switch over to stand-by (even if the base is on) and the handheld will automatically shut off
after approximately five minutes of non-use to save battery power.

BATTERIES AND CHARGE LEVEL INDICATION:


The handheld runs on two standard AA alkaline batteries to assure sufficient stand-alone operation.
The charge level of the batteries is shown on the screen as follows:

Battery fully charged (no symbol appears in the area that shows the battery charge level).

Battery half-charged.

Battery charge level low or almost dead (causing the handheld to automatically shut off).

NOTE: The batteries should be removed from the handheld if it is not going to be used for an extended period.

WIRED HANDHELD
NOTE: This section applies only to models RX DC REF: MRPU***C*, MRXU***C*
(Character * can be any alphanumeric value)

AUTOMATIC HANDHELD SHUT OFF:


The handheld will automatically turn off after switching off the control unit.

18 OPERATOR'S MANUAL EN
4.1. HANDHELD DISPLAY FUNCTIONS

1 Field present for dialoguing with “base”


2 Pause for cooling
3 Handheld identification number
4 Memorising
5 Battery status
6 Patient size selection
7 8” round collimator on (12” rectangular collimator not attached)
8 Interlock active
9 Graduated bar for thermal load
10 Time/dose unit of measure
11 Exposure time and dose display
12 Tooth selection

EN OPERATOR'S MANUAL 19
4.2. USE OF HANDHELD

As illustrated in the figure below, the handheld has four function keys and a single x-ray emission key.

1 “Dentition area selection” key


2 “Body size selection” key
3 X-ray emission light
4 “Increase” key
5 “Decrease” key
6 “X-ray emission” key
The main functions of the keys on the handheld, depending on how they are pressed, are:
KEY BRIEFLY PRESSED (less than 3 sec.). PRESSED LONGER (more than 3 sec.).
Changes over from ADULT to CHILD and Saves the selected setting (exposure time,
vice versa (takes place when key is
released). sensitivity, etc…). The memo icon ( ) lights up
when the data item can be saved.
Selects the various types of teeth to choose Displays the values corresponding to the tooth
the area to be examined. exposure times in mGy and in mGy*cm2 if pressed
again.

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.

20 OPERATOR'S MANUAL EN
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.

4.3. CHECKING THE PARAMETERS

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.

- Checking the selected body build.


- “Child” selected: indicates the x-ray unit is set for patients with small builds.
- “Adult” selected: indicates the x-ray unit is set for patients with average-large builds.

Average/large build (ADULT) selected Small build (child) selected

NOTE: After the change has been made, the preset exposure times will automatically be modified.

EN OPERATOR'S MANUAL 21
- Checking the selected type of intraoral exam.

Upper molars Lower incisors

Upper canines/bicuspids or rear


Lower canines/bicuspids
”bite-wing”

Upper incisors
Lower molars
or front ”bitewing”

4.4. FACTORY SETTINGS

RX DC x-ray unit is supplied with the following factory settings:


- Operative mode: AUTO.
- Sensitivity: level 19.
- Handheld stand-by: 5 minutes
- Exposure times as per standard R'20: 0.020 - 0.022 - 0.025 - 0.028 - 0.032 - 0.036 - 0.040 - 0.045 - 0.050 - 0.056
- 0.063 - 0.071 - 0.080 - 0.090 - 0.100 - 0.110 - 0.125 - 0.140 - 0.160 - 0.180 - 0.200 - 0.220 - 0.250 - 0.280 - 0.320
- 0.360 - 0.400 - 0.450 - 0.500 - 0.560 - 0.630 - 0.710 - 0.800 - 0.900 - 1.000
NOTE: These times comply with current standards I.E.C. 60601-1-3:2008 and the ISO 497 series R’20
recommendations and CANNOT BE MODIFIED.

22 OPERATOR'S MANUAL EN
5. USE OF THE X-RAY DEVICE

5.1. PATIENT POSITIONING

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.

5.2. POSITIONING THE X-RAY HEAD

Position the x-ray head so that the cone is aligned with the image receiver.

BALL JOINT TECHNOLOGY

NOTE: This section applies only to models RX DC REF: MRPU*****


(Character * can be any alphanumeric value)

In the versions equipped with ball joint, the x-ray head can freely rotate on both
its horizontal and vertical axis.
An electromechanical brake initially locks the x-ray head. To release the head
and let it rotate on the positioning ball, work on the touch sensitive unlocking
areas located on it (see points A in the figure on the side).
Touching the unlocking areas allows positioning the x-ray head at the desired
angle to perform the exposure. To lock it again, simply release the unlocking
areas.

NOTE: Firmly hold the x-ray head with both hands when putting it in place.

It is possible to set a safety unlocking mode that allows the head to be turned only by pressing both unlocking buttons.
This prevents the head from unlocking unexpectedly after one of the two unlocking buttons has been accidentally
pressed. To activate this mode, refer to section 5 “Advanced options”.

ARCH TECHNOLOGY

NOTE: This section applies only to models RX DC REF: MRXU*****


(Character * can be any alphanumeric value)

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.

EN OPERATOR'S MANUAL 23
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

24 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.

5.4. SETTING THE EXPOSURE MODE AND TIME

The exposure parameters are set by following the directions given below:
1) Select the tooth to be examined
2) Select the patient size

The exposure time is automatically shown on the handheld screen.

NOTE: Each tooth and patient size selected is displayed for approximately 1 second according to the
operating mode used (En60, En63 o En65).

NOTE: This section applies only to models RX DC REF: MRPU*6***, MRXU*6***


(Character * can be any alphanumeric value)

NOTE: This section applies only to models RX DC REF: MRPU*7***, MRXU*7***


(Character * can be any alphanumeric value)

The suggested exposure time can be changed with keys and . Exposure times ranging from 0.02s to 1.00s

belonging to the R'20 scale can be set. Random exposure times different from the ones provided in the R’20 scale

cannot be set.

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.

EN OPERATOR'S MANUAL 25
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 the

same time; the actual sensitivity factor will be displayed.

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 to confirm. The change made to the sensitivity factor is

applied to all the teeth and both patient sizes.


The operating mode selected is always used for each combination of tooth and patient size.
In AUTO mode, each tooth and patient size combination is associated to the best mode from amongst the ones
available. In this mode, it is not possible to assign a mode other than the default one to each combination.

26 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.

- Tell the patient to stay still.


- Press and hold down the “Exposure” key on the handheld until the audible warning sound (beep) stops and the
yellow light goes out.

"X-ray emission light" key

Light on control panel illuminated during x-ray emission.

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.

EN OPERATOR'S MANUAL 27
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).

SETTING THE SAFETY UNLOCKING MODE

NOTE: This section applies only to models RX DC REF: MRPU*****


(Character * can be any alphanumeric value)

X-ray unit has a safety unlocking mode for the ball joint.
The default setting allows the ball joint to be disengaged by simply touching one of the buttons present on the front of
the head. To prevent accidental contact with the buttons unexpectedly disengaging the ball joint (and therefore causing
undesired movement of the head), the safety unlocking mode can be activated. In this mode, the ball joint is disengaged
only if both buttons are activated at the same time.

To set the safety unlocking mode, press keys and to go to the set-up menu.

Scroll the parameters up to parameter P05 and press key . Scroll the options to select “ON” and then press key

Press key to quit the setup menu.

28 OPERATOR'S MANUAL EN
6.1. SETTING THE OPERATING MODE

X-ray unit features the following operating modes:


- AUTO: the system automatically selects the best setting available for each tooth-patient size combination
- USER: the system automatically proposes the optimum exposure time according to the selected tooth and patient
size - En65: all exposures are performed at 65KV and 6mA.

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: MRPU*6***, MRXU*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

NOTE: This section applies only to models RX DC REF: MRPU*7***, MRXU*7***


(Character * can be any alphanumeric value)

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

and then press key .

Press key to quit the setup menu.

EN OPERATOR'S MANUAL 29
6.2. SETTING TYPE OF MOVABLE COLLIMATOR

X-ray unit features the following movable collimators:


- Rectangular 35x45 mm (only with ball joint)
- Round ø55 mm
- Rectangular 31x41 mm (to apply on round collimator ø55 mm)
- Rectangular 22x35 mm (to apply on round collimator ø55 mm)

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

and then press key .

Press key to quit the setup menu.

6.3. RESTORING FACTORY SETTINGS

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.

30 OPERATOR'S MANUAL EN
7. ERROR MESSAGES

ERROR
ERROR TYPE DESCRIPTION SOLUTION
CODE

Check that the external shooting button is not locked


GENERAL External shooting button
W0002 (remove the K4 connector in the base board and restart
WARNING pressed upon start-up
the machine).

The warning signals that the x-ray unit does not contain
GENERAL Configuration data reading configuration data. Perform the handheld pairing
W0005
WARNING error procedure and if the warning persists after restarting
the machine contact the service department.

This warning can occur after the x-ray unit board is


replaced or after a complete reset of the latter. The
warning signals that the x-ray unit has a tube calibration
inconsistent with the type of machine. Check the
GENERAL Missing or wrong tube configuration of the DIP-SWITCHES of the x-ray unit
W006
WARNING calibration board. If the configuration does not correspond it is
necessary to modify the DIP-SWITCHES (Copy the
dip-switch position from the board that is being
replaced) restart the machine and perform the tube
calibration procedure.

This warning can occur after the x-ray unit board is


replaced or after a complete reset of the latter. The
GENERAL Calibration data reading
W007 warning signals that the x-ray unit does not contain tube
WARNING error
calibration data. Perform the tube calibration
procedure.

Incorrect DSP parameters. Incorrect technical parameters. If the problem persists


X-RAY UNIT
E102 X-ray emission start-up after restarting the machine contact the service
ERROR
failure. department

X-RAY UNIT Mains voltage lower than Check the power supplied to the machine. The
E104
ERROR 260 V. shooting cycle cannot start until it is restored.

E105 X-RAY UNIT Try to repeat exposure. If the problem persists replace
Software error
E107 ERROR the x-ray unit control board.

Excessive anodic voltage detected. Check monobloc/x-


E130 DSP ERROR Overvoltage error
ray unit feedback wire. Possible monobloc fault.

Excessive anodic current detected. Check monobloc/x-


E131 DSP ERROR Overcurrent error
ray unit feedback wire. Possible monobloc fault.

Insufficient or anomalous anodic voltage. Check


Loss of anodic voltage
E132 DSP ERROR monobloc/x-ray unit feedback wire and arm cable.
regulation
Possible monobloc or base board fault.

Insufficient or anomalous anodic current. Check


Loss of anodic current
E133 DSP ERROR monobloc/x-ray unit feedback wire and arm cable.
regulation
Possible monobloc or base board fault.

Anodic voltage other than zero detected with generator


Anodic voltage other than
E134 DSP ERROR off. Check monobloc/x-ray unit feedback wire. Possible
zero
x-ray unit board fault.

EN OPERATOR'S MANUAL 31
ERROR
ERROR TYPE DESCRIPTION SOLUTION
CODE

Anodic current other than zero detected with generator


Anodic current other than
E135 DSP ERROR off. Check monobloc/x-ray unit feedback wire. Possible
zero
x-ray unit board fault.

Excessive current detected on filament. Check


Excessive current detected
E136 DSP ERROR monobloc/x-ray unit feedback wire. Possible monobloc
on filament
fault.

Insufficient current detected on filament. Check


E137 DSP ERROR Filament error monobloc/x-ray unit feedback wire. Possible filament
fault.

Excessive offset values detected on analogue films.


X-ray unit board internal
E138 DSP ERROR Check monobloc/x-ray unit feedback wire. Possible x-
error
ray unit board fault.

ACTUATOR Excessive voltage detected on capacitor bench.


E150 Brake overvoltage
ERROR Possible x-ray unit board fault.

Insufficient voltage detected on capacitor bench.


ACTUATOR
E151 Brake undervoltage Possible x-ray unit board fault or short-circuit on
ERROR
actuator.

Excessive current detected on actuator. Check


ACTUATOR
E152 Brake overcurrent actuator cable and capacitor cable. Possible short-
ERROR
circuit on actuator.

Error due to disconnected Insufficient current detected on actuator. Check


ACTUATOR
E153 brake or tripped thermal actuator cable and capacitor cable. Possible fault on
ERROR
cutout actuator or disconnected actuator.

Actuator current other than zero detected with actuator


ACTUATOR
E154 Brake malfunctioning off. Check actuator cable and capacitor cable. Possible
ERROR
fault on actuator or x-ray unit board.

Capacitor bench voltage other than zero detected in


ACTUATOR
E155 Brake malfunctioning standby. Check capacitor cable. Possible x-ray unit
ERROR
board fault.

E200 Generator short-circuit detected. Check arm cable


BASE ERROR Overcurrent error
E201 continuity. Possible monobloc or base board fault.

Unexpected deactivation detected during emission.


E202 BASE ERROR Base board internal error Interlock intervention, possible SW error or base board
or x-ray unit board fault.

E203 Excessive exposure duration detected. Possible SW


BASE ERROR Safety emission interruption
E204 error or base board or x-ray unit board fault.

EXTERNAL X-
E206 External x-ray key released Hold down the key until the image has been captured.
RAY KEY
E211 in advance If the issue persists, replace the external shooting key.
ERROR

Check the pantograph arm cable and restart the


E212 BASE ERROR Firmware update error
machine.

The shooting key must not be active when the machine


is started.
HANDHELD
E300 Shooting key pressed Check that the external shooting button is not locked
ERROR
(remove the K2 connector in the base board and restart
the machine).

32 OPERATOR'S MANUAL EN
ERROR
ERROR TYPE DESCRIPTION SOLUTION
CODE

HANDHELD Shooting key released


E301 Hold down the key until the end of the exposure.
ERROR during emission

Error caused by interferences in the wireless


E302 HANDHELD Wireless handheld communication. Refer to the manual for the procedures
E303 ERROR communication error to select the free channel. This error can occur only with
wireless handheld.

E304 HANDHELD Handheld internal error. Contact the Service


Handheld error
E306 ERROR Department

NOTE: Just press button to exit error condition

NOTE: As regards the other error codes, CONTACT the technical service department.

EN OPERATOR'S MANUAL 33
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.

Period Operator Object Description


1 year Specialised technicians of All device In order to ensure the safety of
the distributor who installed components are operation of the device, it is advisable
the device or other integral parts of the to inspect the x-ray unit in all its parts,
technicians authorised by unit in order to prevent or repair any faults
the Manufacturer

Quality control by means of a dental phantom for image acquiring systems, according to IEC 61223-3-4:2000:

Image resolution (lp/mm) 4lp/mm


Low contrast resolution 2
Artefacts In the image, there must be no artefacts such as visible
horizontal lines
Control period 1 year

The quality control consists in performing a radiological investigation by means of the tested device and a suitable
acquisition system. 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.

34 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 x-ray unit can be a source of cross-contamination between patients.


For this reason it should be disinfected on the outside every day after use.
If digital x-ray sensors are used, make sure that they are always used with disposable hygienic covers.
Use soft disposable paper towels to disinfect the x-ray unit. Do not use harsh products or soak in liquids.
It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA S.C.), which is compatible
with painted surfaces, plastic parts and unpainted metal surfaces. Alternatively, it is recommended to use products that
contain:
- 96% ethanol.
Concentration: maximum 30 g for every 100 g of disinfectant.
- Propanol.
Concentration: maximum 20 g for every 100 g of disinfectant.
- Combination of ethanol and propanol.
Concentration: the combination of the two should be maximum 40 g per 100 g of disinfectant.
Compatibility tests between plastics and the following products have been carried out with no negative consequences:
- Incidin Spezial (Henkel Ecolab);
- Omnizid (Omnident);
- Plastisept (Alpro) (not tuberculocide as not an alcohol-based disinfectant);
- RelyOn Virkosept (DuPont);
- Green & Clean SK (Metasys) (not tuberculocide as not an alcohol-based disinfectant).
- Do not use products containing isopropyl alcohol (2-propanol, iso-propanol).
- Do not use products containing sodium hypochlorite (bleach).
- Do not use products containing phenols.
- Do not spray the selected products directly on the surfaces.
- Never combine products with each other or with liquids other than the products listed above.
- All products must be used as directed by the manufacturer.

- 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.

Cleaning and disinfecting instructions.


Clean and disinfect with disposable soft, non-abrasive paper (avoid using recycled paper) or sterile gauze.
Do not use sponge cloths or, in any case, any material that can be reused.
- Turn off the device prior to cleaning and disinfecting the external parts.
- Never lubricate the pivot point of the x-ray head as proper operation of the locking system may be
compromised.
- All material used to clean and disinfect must be thrown away upon completing the procedure.

EN OPERATOR'S MANUAL 35
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 compliance with Directives 2011/65/EU and 2012/19/EU regarding restriction of the use of certain hazardous
substances in electrical and electronic equipment along with waste electrical and electronic equipment it is forbidden
to dispose of this equipment in the municipal waste stream as unsorted municipal waste.
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 symbol indicating separate collection for electrical and electronic equipment consists of the crossed out bin marked
on the equipment.

WARNING!
Under local legislation, fines can be imposed if the equipment is disposed in an illegal manner.

36 OPERATOR'S MANUAL EN
11. TECHNICAL DATA

NOTE: This section applies only to models RX DC REF: MRPU*7***, MRXU*7***


(Character * can be any alphanumeric value)

Specification for 70kV x-ray head:


- Rated voltage: 230-240 Vac or 115-120 Vac (according
to the model).
- Max. mains voltage fluctuation: ±10%.
- Rated current: 6A for the 230-240Vac version; 10A for
the 115-120Vac version.
- Frequency: 50/60Hz.
- Maximum power absorbed: 1.4KVA.
- Apparent line resistance: 0.5Ω (240Vac), 0.2Ω
(120Vac).
- Protective fuses: 8A T for the 230-240Vac version; 12A
T for the 115-120Vac version.
- Generator: constant potential type.
- High nominal voltage: 60 / 65 / 70 kV.
- Anode current: 4 / 8mA.
- Load factors for the maximum electric power: 70kV
8mA (560W).
- Input anodic continuous power: 7W.
- Current - reference time product: 0.8 mAs (8mA - 0.1s)
/ 0.4 mAs (4mA – 0.1s).
- Focal spot (according to IEC 60336:2005):
0.4mm (with tube CANON / TOSHIBA D-041, Kailong
KL11-0.4-70, CEI OX/70-3)
0.7mm (with tube CANON / TOSHIBA D-0711 or
Kailong KL21-0.7)
- Anode construction material: Tungsten (W).
- Total filtration: 2mm Al @ 60kV.
- Leaked radiation: <0.25mGy / h at 1 metre from focus
with load factor 70kV 8mA 1s and duty cycle 1:80.
- Tolerance for position of the focal spot along the
reference axis: ± 2%.
- Set exposure time: from 0.020 to 1.000 seconds.
- Accuracy of times indicated: ±5% or ±5ms.
- Coefficient of variation of KERMA <0.05.
- Linearity error of KERMA <0.2.
- Dose indication accuracy (mGy): ±30%.
- Maximum deviation of stated values:
kV: < 5%
mA: < 10%
- Operation frequency bands (for versions with wireless
handheld only): 2412 ÷ 2483.5 MHz.
- Maximum power (for versions with wireless handheld
only): +17 dBm

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 37
NOTE: This section applies only to models RX DC REF: MRPU*6***, MRXU*6***
(Character * can be any alphanumeric value)

Specification for 65kV x-ray head:


- Rated voltage: 230-240 Vac or 115-120 Vac (according
to the model).
- Max. mains voltage fluctuation: ±10%.
- Rated current: 6A for the 230-240Vac version; 10A for
the 115-120Vac version.
- Frequency: 50/60Hz.
- Maximum power absorbed: 1.4kVA.
- Apparent line resistance: 0.5Ω (240Vac), 0.2Ω
(120Vac).
- Protective fuses: 8A T for the 230-240Vac version; 12A
T for the 115-120Vac version.
- Generator: constant potential type.
- High nominal voltage: 60 / 63 / 65 kV.
- Rated current: 6 / 7mA.
- Load factors for the maximum electric power: 60kV
7mA (420W).
- Input anodic continuous power: 7W.
- Current - reference time product: 0.7 mAs (7mA - 0.1s)
/ 0.6 mAs (6mA – 0.1s).
- Focal spot (according to IEC 60336:2005):
0.4mm (with tube CANON / TOSHIBA D-041, Kailong
KL11-0.4-70, CEI OX/70-3)
0.7mm (with tube CANON / TOSHIBA D-0711 or
Kailong KL21-0.7)
- Anode construction material: Tungsten (W).
- Total filtration: 2mm Al @ 60kV.
- Leaked radiation: <0.25mGy / h at 1 metre from focus
with load factor 65kV 6mA 1s and duty cycle 1:60.
- Tolerance for position of the focal spot along the
reference axis: ± 2%.
- Set exposure time: from 0.020 to 1.000 seconds.
- Accuracy of times indicated: ±5%.
- Coefficient of variation <0.05.
- Linearity error <0.2.
- Dose indication accuracy (mGy): ±30%.
- Maximum deviation of stated values:
kV: < 5%
mA: < 10%
- Operation frequency bands (for versions with wireless
handheld only): 2412 ÷ 2483.5 MHz.
- Maximum power (for versions with wireless handheld
only): +17 dBm

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).

38 OPERATOR'S MANUAL EN
11.1. X-RAY TUBES

X-RAY TUBE CANON / TOSHIBA D-041, CANON /


TOSHIBA D-045, Kailong KL11-0.4-70
- Anode inclination: 12.5° (with tube CANON / TOSHIBA
D-041, CANON / TOSHIBA D-045)
- Anode inclination: 12° (with Kailong KL11-0,4-70)
- Anode thermal load: 4.3 KJ

X-RAY TUBE CEI OX/70-3


- Anode inclination: 13°
- Anode thermal load: 7 KJ
- Maximum continuous heat dissipation: 100 W.
- Operating cycle: 1:60 (1 second exposure - 60 seconds
pause time).

EN OPERATOR'S MANUAL 39
X-RAY TUBE CANON / 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).

COLLIMATOR TECHNICAL SPECIFICATIONS


- With rectangular collimator: SSD=30cm (12”), x-ray
beam less than or equal to 45x35mm.
- With round collimator: SSD=30cm (12”), x-ray beam
less than or equal to 55mm.
- Without rectangular collimator: SSD=20cm (8”), x-ray
beam less than or equal to Ø60mm.
A) REFERENCE AXIS
B) FOCAL SPOT IDENTIFICATION

11.2. TECHNICAL FACTOR MEASURE

The high voltage value is measured with a non-invasive instrument.


The anode current is controlled inside with measurement resistors and circuits to obtain very precise measurements.
Operation of the circuits is checked at the time of testing. Once assembled, the anode current can no longer be directly
measured.
The exposure time should be evaluated by measuring the time that elapses from the moment in which high voltage
exceeds 75% of the nominal value to the moment in which it drops below this value. Considering the high gradient of
the rising and trailing edges of the anode voltage and squaring due to inherent filtration, use of a threshold ranging
from 25% to 75% may be considered non-influential.

40 OPERATOR'S MANUAL EN
12. DIMENSIONAL CHARACTERISTICS

WALL-MOUNTED VERSION WITH ARCH

NOTE: This section applies only to models RX DC REF: MRXU****S


(Character * can be any alphanumeric value)

All dimensions are expressed in millimetres (inches).

EN OPERATOR'S MANUAL 41
42 OPERATOR'S MANUAL EN
WALL-MOUNTED VERSION WITH BALL JOINT

NOTE: This section applies only to models RX DC REF: MRPU****S


(Character * can be any alphanumeric value)

All dimensions are expressed in millimetres (inches).

EN OPERATOR'S MANUAL 43
44 OPERATOR'S MANUAL EN
INTEGRATED VERSION

NOTE: This section applies only to models RX DC REF: MRPU****I


(Character * can be any alphanumeric value)

All dimensions are expressed in millimetres (inches).

EN OPERATOR'S MANUAL 45
MOBILE STAND VERSION

NOTE: This section applies only to models RX DC REF: MRXU****M


(Character * can be any alphanumeric value)

All dimensions are expressed in millimetres (inches).

46 OPERATOR'S MANUAL EN
EN OPERATOR'S MANUAL 47
13. IDENTIFICATION PLATES

WARNING:
Never remove the identification nameplates provided on the generator, control unit and collimator cone.

NOTE: This section applies only to models RX DC REF: MRPU****S


(Character * can be any alphanumeric value)

Control unit (MAIN NAMEPLATE).


The nameplate is located beside the main switch
Data given on plate:
- Name and address of the Manufacturer.
- Brand and model of equipment.
- Rated voltage.
- Type of current.
- Rated frequency.
- Maximum current absorbed.
- Serial number.
- Month and year of manufacture.
- Approval marks.
- Symbol required by standards.

NOTE: This section applies only to models RX DC REF: MRPU****I


(Character * can be any alphanumeric value)

Control unit (MAIN NAMEPLATE).


The plate is located under the extension arm.
Data given on plate:
- Name and address of the Manufacturer.
- Brand and model of equipment.
- Rated voltage.
- Type of current.
- Rated frequency.
- Maximum current absorbed.
- Serial number.
- Month and year of manufacture.
- Approval marks.
- Symbol required by standards.

NOTE: This section applies only to models RX DC REF: MRXU****M


(Character * can be any alphanumeric value)

Control unit (MAIN NAMEPLATE).


The nameplate is located beside the main switch.
Data given on plate:
- Name and address of the Manufacturer.
- Brand and model of equipment.
- Rated voltage.
- Type of current.
- Rated frequency.
- Maximum current absorbed.
- Serial number.
- Month and year of manufacture.
- Approval marks.
- Symbol required by standards.

48 OPERATOR'S MANUAL EN
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 the 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.

Collimator.
The nameplate for the rectangular collimator is found
outside it.
Data given on plates:
- Name and address of the Manufacturer.
- Equipment code.
- Technical data.
- DHHS compliance.
- Serial number.
- Month and year of manufacture.

NOTE: This section applies only to models RX DC REF: MRPU***W*, MRXU***W*


(Character * can be any alphanumeric value)

Wireless handheld.
The nameplate for the handheld is found in the battery
compartment.
Data given on plate:
- Name of the Manufacturer.
- Name of equipment.
- Rated voltage.
- Number and type of batteries.
- Serial number.

NOTE: This section applies only to models RX DC REF: MRPU***C*, MRXU***C*


(Character * can be any alphanumeric value)

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.

EN OPERATOR'S MANUAL 49
14. TIMES/SENSITIVITY CHARTS

When using the x-ray unit, in conjunction with the intraoral sensor of the Manufacturer, it is recommended to use a
default value of sensitivity equal to F15.
If using phosphorous plates of the Manufacturer, it is recommended to set a sensitivity value equal to F16.
For the analogue films the optimum sensitivity is F19.
For sensors other than the previous ones, 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).

NOTE: This section applies only to models RX DC REF: MRPU*6***, MRXU*6***


(Character * can be any alphanumeric value)

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 0.200 0.125 0.180 0.110 0.160 0.100 0.400 0.250 0.360 0.220 0.320 0.200
“bitewing”
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

NOTE: This section applies only to models RX DC REF: MRPU*7***, MRXU*7***


(Character * can be any alphanumeric value)

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 0.180 0.110 0.125 0.080 0.110 0.063 0.360 0.220 0.250 0.160 0.220 0.140
“bitewing”
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

50 OPERATOR'S MANUAL EN
15. NOMINAL DOSE EMISSION VALUES

Dose in air @ 200 mm 60 kV 63 kV 65 kV 70 kV


mGy/mAs (± 40%) 1.22 1.33 1.41 1.59

NOTE: This section applies only to models RX DC REF: *****6***


(Character * can be any alphanumeric value)

Nominal emission values according to time and type of collimator:


Collimator Round ø 60 mm
SSD 200 mm
A (cm2) 28.26
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 0.17 4.8 0.16 4.5 0.17 4.8
0.022 0.19 5.3 0.18 5.0 0.19 5.3
0.025 0.21 6.0 0.20 5.6 0.21 6.0
0.028 0.24 6.8 0.22 6.3 0.24 6.7
0.032 0.27 7.7 0.26 7.2 0.27 7.7
0.036 0.31 8.7 0.29 8.1 0.30 8.6
0.040 0.34 9.7 0.32 9.0 0.34 9.6
0.045 0.38 10.9 0.36 10.1 0.38 10.8
0.050 0.43 12.1 0.40 11.3 0.42 12.0
0.056 0.48 13.5 0.45 12.6 0.47 13.4
0.063 0.54 15.2 0.50 14.2 0.53 15.1
0.071 0.61 17.1 0.57 16.0 0.60 17.0
0.080 0.68 19.3 0.64 18.0 0.68 19.1
0.090 0.77 21.7 0.72 20.3 0.76 21.5
0.100 0.85 24.1 0.80 22.6 0.85 23.9
0.110 0.94 26.5 0.88 24.8 0.93 26.3
0.125 1.07 30.2 1.00 28.2 1.06 29.9
0.140 1.20 33.8 1.12 31.6 1.18 33.5
0.160 1.37 38.6 1.28 36.1 1.35 38.3
0.180 1.54 43.4 1.44 40.6 1.52 43.0
0.200 1.71 48.3 1.60 45.1 1.69 47.8
0.220 1.88 53.1 1.76 49.6 1.86 52.6
0.250 2.14 60.3 2.00 56.4 2.12 59.8
0.280 2.39 67.6 2.23 63.1 2.37 66.9
0.320 2.73 77.2 2.55 72.2 2.71 76.5
0.360 3.07 86.9 2.87 81.2 3.05 86.1
0.400 3.42 96.5 3.19 90.2 3.38 95.6
0.450 3.84 108.6 3.59 101.5 3.81 107.6
0.500 4.27 120.7 3.99 112.8 4.23 119.5
0.560 4.78 135.2 4.47 126.3 4.74 133.9
0.630 5.38 152.0 5.03 142.1 5.33 150.6
0.710 6.06 171.4 5.67 160.1 6.01 169.7
0.800 6.83 193.1 6.38 180.4 6.77 191.3
0.900 7.69 217.2 7.18 203.0 7.61 215.2
1.000 8.54 241.3 7.98 225.5 8.46 239.1

EN OPERATOR'S MANUAL 51
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)

Nominal emission values according to time and type of collimator:


Collimator Round ø 60 mm
SSD 200 mm
A (cm2) 28.26
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 0.20 5.5 0.23 6.4 0.25 7.2
0.022 0.21 6.1 0.25 7.0 0.28 7.9
0.025 0.24 6.9 0.28 8.0 0.32 9.0
0.028 0.27 7.7 0.32 8.9 0.36 10.1
0.032 0.31 8.8 0.36 10.2 0.41 11.5
0.036 0.35 9.9 0.41 11.5 0.46 12.9
0.040 0.39 11.0 0.45 12.8 0.51 14.4
0.045 0.44 12.4 0.51 14.3 0.57 16.2
0.050 0.49 13.8 0.56 15.9 0.64 18.0
0.056 0.55 15.4 0.63 17.9 0.71 20.1
0.063 0.61 17.4 0.71 20.1 0.80 22.6
0.071 0.69 19.6 0.80 22.6 0.90 25.5
0.080 0.78 22.1 0.90 25.5 1.02 28.8
0.090 0.88 24.8 1.02 28.7 1.14 32.4
0.100 0.98 27.6 1.13 31.9 1.27 35.9
0.110 1.07 30.3 1.24 35.1 1.40 39.5
0.125 1.22 34.5 1.41 39.8 1.59 44.9
0.140 1.37 38.6 1.58 44.6 1.78 50.3
0.160 1.56 44.1 1.80 51.0 2.04 57.5
0.180 1.76 49.6 2.03 57.4 2.29 64.7
0.200 1.95 55.2 2.26 63.8 2.54 71.9
0.220 2.15 60.7 2.48 70.1 2.80 79.1
0.250 2.44 69.0 2.82 79.7 3.18 89.9
0.280 2.73 77.2 3.16 89.3 3.56 100.7
0.320 3.12 88.3 3.61 102.0 4.07 115.0
0.360 3.51 99.3 4.06 114.8 4.58 129.4
0.400 3.90 110.3 4.51 127.5 5.09 143.8
0.450 4.39 124.1 5.08 143.4 5.72 161.8
0.500 4.88 137.9 5.64 159.4 6.36 179.7
0.560 5.47 154.5 6.32 178.5 7.12 201.3
0.630 6.15 173.8 7.11 200.8 8.01 226.5
0.710 6.93 195.8 8.01 226.3 9.03 255.2
0.800 7.81 220.7 9.02 255.0 10.18 287.6
0.900 8.78 248.2 10.15 286.9 11.45 323.5
1.000 9.76 275.8 11.28 318.8 12.72 359.5

52 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)

Collimator Rectangular 35x45 mm


SSD 30 cm
A (cm2) 15.75
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 1.3 0.08 1.3 0.08 1.3
0.022 0.09 1.5 0.09 1.4 0.09 1.5
0.025 0.11 1.7 0.10 1.6 0.11 1.7
0.028 0.12 1.9 0.11 1.8 0.12 1.9
0.032 0.14 2.2 0.13 2.0 0.14 2.1
0.036 0.15 2.4 0.14 2.3 0.15 2.4
0.040 0.17 2.7 0.16 2.5 0.17 2.7
0.045 0.19 3.0 0.18 2.8 0.19 3.0
0.050 0.21 3.4 0.20 3.1 0.21 3.3
0.056 0.24 3.8 0.22 3.5 0.24 3.7
0.063 0.27 4.2 0.25 4.0 0.27 4.2
0.071 0.30 4.8 0.28 4.5 0.30 4.7
0.080 0.34 5.4 0.32 5.0 0.34 5.3
0.090 0.38 6.1 0.36 5.7 0.38 6.0
0.100 0.43 6.7 0.40 6.3 0.42 6.7
0.110 0.47 7.4 0.44 6.9 0.47 7.3
0.125 0.53 8.4 0.50 7.9 0.53 8.3
0.140 0.60 9.4 0.56 8.8 0.59 9.3
0.160 0.68 10.8 0.64 10.1 0.68 10.7
0.180 0.77 12.1 0.72 11.3 0.76 12.0
0.200 0.85 13.5 0.80 12.6 0.85 13.3
0.220 0.94 14.8 0.88 13.8 0.93 14.7
0.250 1.07 16.8 1.00 15.7 1.06 16.7
0.280 1.20 18.8 1.12 17.6 1.18 18.7
0.320 1.37 21.5 1.28 20.1 1.35 21.3
0.360 1.54 24.2 1.44 22.6 1.52 24.0
0.400 1.71 26.9 1.60 25.1 1.69 26.6
0.450 1.92 30.3 1.80 28.3 1.90 30.0
0.500 2.14 33.6 2.00 31.4 2.12 33.3
0.560 2.39 37.7 2.23 35.2 2.37 37.3
0.630 2.69 42.4 2.51 39.6 2.66 42.0
0.710 3.03 47.7 2.83 44.6 3.00 47.3
0.800 3.42 53.8 3.19 50.3 3.38 53.3
0.900 3.84 60.5 3.59 56.6 3.81 60.0
1.000 4.27 67.3 3.99 62.8 4.23 66.6

EN OPERATOR'S MANUAL 53
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)

Collimator Rectangular 35x45 mm


SSD 30 cm
A (cm2) 15.75
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 1.5 0.11 1.8 0.13 2.0
0.022 0.11 1.7 0.12 2.0 0.14 2.2
0.025 0.12 1.9 0.14 2.2 0.16 2.5
0.028 0.14 2.2 0.16 2.5 0.18 2.8
0.032 0.16 2.5 0.18 2.8 0.20 3.2
0.036 0.18 2.8 0.20 3.2 0.23 3.6
0.040 0.20 3.1 0.23 3.6 0.25 4.0
0.045 0.22 3.5 0.25 4.0 0.29 4.5
0.050 0.24 3.8 0.28 4.4 0.32 5.0
0.056 0.27 4.3 0.32 5.0 0.36 5.6
0.063 0.31 4.8 0.36 5.6 0.40 6.3
0.071 0.35 5.5 0.40 6.3 0.45 7.1
0.080 0.39 6.1 0.45 7.1 0.51 8.0
0.090 0.44 6.9 0.51 8.0 0.57 9.0
0.100 0.49 7.7 0.56 8.9 0.64 10.0
0.110 0.54 8.5 0.62 9.8 0.70 11.0
0.125 0.61 9.6 0.71 11.1 0.80 12.5
0.140 0.68 10.8 0.79 12.4 0.89 14.0
0.160 0.78 12.3 0.90 14.2 1.02 16.0
0.180 0.88 13.8 1.02 16.0 1.14 18.0
0.200 0.98 15.4 1.13 17.8 1.27 20.0
0.220 1.07 16.9 1.24 19.5 1.40 22.0
0.250 1.22 19.2 1.41 22.2 1.59 25.0
0.280 1.37 21.5 1.58 24.9 1.78 28.0
0.320 1.56 24.6 1.80 28.4 2.04 32.1
0.360 1.76 27.7 2.03 32.0 2.29 36.1
0.400 1.95 30.7 2.26 35.5 2.54 40.1
0.450 2.20 34.6 2.54 40.0 2.86 45.1
0.500 2.44 38.4 2.82 44.4 3.18 50.1
0.560 2.73 43.0 3.16 49.7 3.56 56.1
0.630 3.07 48.4 3.55 56.0 4.01 63.1
0.710 3.46 54.6 4.00 63.1 4.52 71.1
0.800 3.90 61.5 4.51 71.1 5.09 80.1
0.900 4.39 69.2 5.08 79.9 5.72 90.2
1.000 4.88 76.9 5.64 88.8 6.36 100.2

54 OPERATOR'S MANUAL EN
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

EN OPERATOR'S MANUAL 55
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

56 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)

Collimator Rectangular 22x35 mm


SSD 31 cm
A (cm2) 7.70
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 0.7 0.08 0.6 0.08 0.7
0.022 0.09 0.7 0.09 0.7 0.09 0.7
0.025 0.11 0.8 0.10 0.8 0.11 0.8
0.028 0.12 0.9 0.11 0.9 0.12 0.9
0.032 0.14 1.1 0.13 1.0 0.14 1.0
0.036 0.15 1.2 0.14 1.1 0.15 1.2
0.040 0.17 1.3 0.16 1.2 0.17 1.3
0.045 0.19 1.5 0.18 1.4 0.19 1.5
0.050 0.21 1.6 0.20 1.5 0.21 1.6
0.056 0.24 1.8 0.22 1.7 0.24 1.8
0.063 0.27 2.1 0.25 1.9 0.27 2.1
0.071 0.30 2.3 0.28 2.2 0.30 2.3
0.080 0.34 2.6 0.32 2.5 0.34 2.6
0.090 0.38 3.0 0.36 2.8 0.38 2.9
0.100 0.43 3.3 0.40 3.1 0.42 3.3
0.110 0.47 3.6 0.44 3.4 0.47 3.6
0.125 0.53 4.1 0.50 3.8 0.53 4.1
0.140 0.60 4.6 0.56 4.3 0.59 4.6
0.160 0.68 5.3 0.64 4.9 0.68 5.2
0.180 0.77 5.9 0.72 5.5 0.76 5.9
0.200 0.85 6.6 0.80 6.1 0.85 6.5
0.220 0.94 7.2 0.88 6.8 0.93 7.2
0.250 1.07 8.2 1.00 7.7 1.06 8.1
0.280 1.20 9.2 1.12 8.6 1.18 9.1
0.320 1.37 10.5 1.28 9.8 1.35 10.4
0.360 1.54 11.8 1.44 11.1 1.52 11.7
0.400 1.71 13.2 1.60 12.3 1.69 13.0
0.450 1.92 14.8 1.80 13.8 1.90 14.7
0.500 2.14 16.4 2.00 15.4 2.12 16.3
0.560 2.39 18.4 2.23 17.2 2.37 18.2
0.630 2.69 20.7 2.51 19.4 2.66 20.5
0.710 3.03 23.3 2.83 21.8 3.00 23.1
0.800 3.42 26.3 3.19 24.6 3.38 26.1
0.900 3.84 29.6 3.59 27.7 3.81 29.3
1.000 4.27 32.9 3.99 30.7 4.23 32.6

EN OPERATOR'S MANUAL 57
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)

Collimator Rectangular 22x35 mm


SSD 31 cm
A (cm2) 7.70
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 0.8 0.11 0.9 0.13 1.0
0.022 0.11 0.8 0.12 1.0 0.14 1.1
0.025 0.12 0.9 0.14 1.1 0.16 1.2
0.028 0.14 1.1 0.16 1.2 0.18 1.4
0.032 0.16 1.2 0.18 1.4 0.20 1.6
0.036 0.18 1.4 0.20 1.6 0.23 1.8
0.040 0.20 1.5 0.23 1.7 0.25 2.0
0.045 0.22 1.7 0.25 2.0 0.29 2.2
0.050 0.24 1.9 0.28 2.2 0.32 2.4
0.056 0.27 2.1 0.32 2.4 0.36 2.7
0.063 0.31 2.4 0.36 2.7 0.40 3.1
0.071 0.35 2.7 0.40 3.1 0.45 3.5
0.080 0.39 3.0 0.45 3.5 0.51 3.9
0.090 0.44 3.4 0.51 3.9 0.57 4.4
0.100 0.49 3.8 0.56 4.3 0.64 4.9
0.110 0.54 4.1 0.62 4.8 0.70 5.4
0.125 0.61 4.7 0.71 5.4 0.80 6.1
0.140 0.68 5.3 0.79 6.1 0.89 6.9
0.160 0.78 6.0 0.90 6.9 1.02 7.8
0.180 0.88 6.8 1.02 7.8 1.14 8.8
0.200 0.98 7.5 1.13 8.7 1.27 9.8
0.220 1.07 8.3 1.24 9.6 1.40 10.8
0.250 1.22 9.4 1.41 10.9 1.59 12.2
0.280 1.37 10.5 1.58 12.2 1.78 13.7
0.320 1.56 12.0 1.80 13.9 2.04 15.7
0.360 1.76 13.5 2.03 15.6 2.29 17.6
0.400 1.95 15.0 2.26 17.4 2.54 19.6
0.450 2.20 16.9 2.54 19.5 2.86 22.0
0.500 2.44 18.8 2.82 21.7 3.18 24.5
0.560 2.73 21.0 3.16 24.3 3.56 27.4
0.630 3.07 23.7 3.55 27.4 4.01 30.9
0.710 3.46 26.7 4.00 30.8 4.52 34.8
0.800 3.90 30.1 4.51 34.7 5.09 39.2
0.900 4.39 33.8 5.08 39.1 5.72 44.1
1.000 4.88 37.6 5.64 43.4 6.36 49.0

58 OPERATOR'S MANUAL EN
NOTE: This section applies only to models RX DC REF: *****6***
(Character * can be any alphanumeric value)

Collimator Rectangular 31x41 mm


SSD 31 cm
A (cm2) 12.71
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 1.1 0.08 1.0 0.08 1.1
0.022 0.09 1.2 0.09 1.1 0.09 1.2
0.025 0.11 1.4 0.10 1.3 0.11 1.3
0.028 0.12 1.5 0.11 1.4 0.12 1.5
0.032 0.14 1.7 0.13 1.6 0.14 1.7
0.036 0.15 2.0 0.14 1.8 0.15 1.9
0.040 0.17 2.2 0.16 2.0 0.17 2.2
0.045 0.19 2.4 0.18 2.3 0.19 2.4
0.050 0.21 2.7 0.20 2.5 0.21 2.7
0.056 0.24 3.0 0.22 2.8 0.24 3.0
0.063 0.27 3.4 0.25 3.2 0.27 3.4
0.071 0.30 3.9 0.28 3.6 0.30 3.8
0.080 0.34 4.3 0.32 4.1 0.34 4.3
0.090 0.38 4.9 0.36 4.6 0.38 4.8
0.100 0.43 5.4 0.40 5.1 0.42 5.4
0.110 0.47 6.0 0.44 5.6 0.47 5.9
0.125 0.53 6.8 0.50 6.3 0.53 6.7
0.140 0.60 7.6 0.56 7.1 0.59 7.5
0.160 0.68 8.7 0.64 8.1 0.68 8.6
0.180 0.77 9.8 0.72 9.1 0.76 9.7
0.200 0.85 10.9 0.80 10.1 0.85 10.8
0.220 0.94 11.9 0.88 11.2 0.93 11.8
0.250 1.07 13.6 1.00 12.7 1.06 13.4
0.280 1.20 15.2 1.12 14.2 1.18 15.1
0.320 1.37 17.4 1.28 16.2 1.35 17.2
0.360 1.54 19.5 1.44 18.3 1.52 19.4
0.400 1.71 21.7 1.60 20.3 1.69 21.5
0.450 1.92 24.4 1.80 22.8 1.90 24.2
0.500 2.14 27.1 2.00 25.4 2.12 26.9
0.560 2.39 30.4 2.23 28.4 2.37 30.1
0.630 2.69 34.2 2.51 31.9 2.66 33.9
0.710 3.03 38.5 2.83 36.0 3.00 38.2
0.800 3.42 43.4 3.19 40.6 3.38 43.0
0.900 3.84 48.8 3.59 45.6 3.81 48.4
1.000 4.27 54.3 3.99 50.7 4.23 53.8

EN OPERATOR'S MANUAL 59
NOTE: This section applies only to models RX DC REF: *****7***
(Character * can be any alphanumeric value)

Collimator Rectangular 31x41 mm


SSD 31 cm
A (cm2) 12.71
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 1.2 0.11 1.4 0.13 1.6
0.022 0.11 1.4 0.12 1.6 0.14 1.8
0.025 0.12 1.6 0.14 1.8 0.16 2.0
0.028 0.14 1.7 0.16 2.0 0.18 2.3
0.032 0.16 2.0 0.18 2.3 0.20 2.6
0.036 0.18 2.2 0.20 2.6 0.23 2.9
0.040 0.20 2.5 0.23 2.9 0.25 3.2
0.045 0.22 2.8 0.25 3.2 0.29 3.6
0.050 0.24 3.1 0.28 3.6 0.32 4.0
0.056 0.27 3.5 0.32 4.0 0.36 4.5
0.063 0.31 3.9 0.36 4.5 0.40 5.1
0.071 0.35 4.4 0.40 5.1 0.45 5.7
0.080 0.39 5.0 0.45 5.7 0.51 6.5
0.090 0.44 5.6 0.51 6.5 0.57 7.3
0.100 0.49 6.2 0.56 7.2 0.64 8.1
0.110 0.54 6.8 0.62 7.9 0.70 8.9
0.125 0.61 7.8 0.71 9.0 0.80 10.1
0.140 0.68 8.7 0.79 10.0 0.89 11.3
0.160 0.78 9.9 0.90 11.5 1.02 12.9
0.180 0.88 11.2 1.02 12.9 1.14 14.6
0.200 0.98 12.4 1.13 14.3 1.27 16.2
0.220 1.07 13.6 1.24 15.8 1.40 17.8
0.250 1.22 15.5 1.41 17.9 1.59 20.2
0.280 1.37 17.4 1.58 20.1 1.78 22.6
0.320 1.56 19.8 1.80 22.9 2.04 25.9
0.360 1.76 22.3 2.03 25.8 2.29 29.1
0.400 1.95 24.8 2.26 28.7 2.54 32.3
0.450 2.20 27.9 2.54 32.3 2.86 36.4
0.500 2.44 31.0 2.82 35.8 3.18 40.4
0.560 2.73 34.7 3.16 40.1 3.56 45.3
0.630 3.07 39.1 3.55 45.2 4.01 50.9
0.710 3.46 44.0 4.00 50.9 4.52 57.4
0.800 3.90 49.6 4.51 57.3 5.09 64.7
0.900 4.39 55.8 5.08 64.5 5.72 72.8
1.000 4.88 62.0 5.64 71.7 6.36 80.8

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%.

60 OPERATOR'S MANUAL EN
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.
Answer questions with yes (√) or not (−)
Inspection DATE
Step Description Reference in User Manual __/__/20__ __/__/20__ __/__/20__ __/__/20__ __/__/20__
Check that all labels located
- on the wall-mounted cover,
1 Section Identification nameplates
- on the x-ray tube
- inside the collimator/s, are intact, correctly applied and readable.
Check there are no external damages to the equipment, which may reduce
2 Section Description of the x-ray unit
protection against radiation.
3 Check the battery level of the wireless remote control. Section Operation of control handheld

4 Check the remote control functionality: buttons must respond to interaction Section Use of control handheld
Check the power switch verifying that the switch is working properly and the main
5 Section Turning the x-ray unit on and off
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 Type of x-ray unit
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!

EN OPERATOR'S MANUAL 61
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.
Answer questions with yes (√) or not (−)
Inspection DATE
Step Description Reference in User Manual __/__/20__ __/__/20__ __/__/20__ __/__/20__ __/__/20__
Check that all labels located
- on the wall-mounted cover,
1 User Manual, Section Identification nameplates
- on the x-ray tube
- inside the collimator/s, are intact, correctly applied and readable.
Check there are no external damages to the equipment, which may reduce
2 User Manual, Section Description of the x-ray unit
protection against radiation.
Pull out the collimator and panel stop ring, take off the screw cover caps and
Technical manual, section Replacement of x-ray unit control base
3 loosen the screws that secure the lower cover. Check there is no oil leakage on
board
the tube-head.
Check the electromechanical brake that locks/unlocks the movement of the
4 Technical Manual, section Actuator unit adjustment
generator and adjust it if necessary – ball joint model units only
Power off the unit and remove the wall mounting cover. Disconnect the unit from
the main power supply and check the condition of the main power supply cable.
5 Technical Manual, section Wall-mounted plate wiring connection
Replace it in case of damage. Connect it back making sure the safety ground is
securely connected. Install the wall-mounted cover back again.
6 Check the battery level of the wireless remote control. User manual, section Operation of control handheld

7 Check the remote control functionality: buttons must respond to interaction User manual, section Use of control handheld
Check the power switch verifying that the switch is working properly and the main
8 User Manual, section Switching the x-ray system on and off
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 units
9 User Manual, section Type of x-ray unit
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 User Manual, Section Performing the exposure

12 Check the scissors arm balance and adjust it if necessary Technical Manual, section Fitting the double pantograph arm

13 Perform a calibration of the x-ray tube housing Technical manual, section User and technician configuration menu

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!

62 OPERATOR'S MANUAL EN

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