Villa Visitor T30 C-DR User manual

User’s Manual
System:
Visitor T30 C-DR
Revision:
B
Version:
OEM
Date:
05/2018
Language:
ENG
File:
218899-01-01-B

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1CREDITS...............................................................................................................................5
1.1 Compliance..................................................................................................................................5
1.2 Manufacturer ...............................................................................................................................5
1.3 Distributor ...................................................................................................................................5
1.4 Publishing details ........................................................................................................................5
1.5 Copyright.....................................................................................................................................5
1.6 Information about User's Manual ................................................................................................6
1.7 Compatibility...............................................................................................................................7
1.8 Training.......................................................................................................................................7
1.9 Use destination ............................................................................................................................7
2SAFETY.................................................................................................................................8
2.1 Warnings and precautions ...........................................................................................................8
2.2 Electrical Safety ........................................................................................................................10
2.3 Mechanical safety......................................................................................................................10
2.4 Protection against explosions ....................................................................................................11
2.5 Fire safety..................................................................................................................................11
2.6 Electrostatic discharge (ESD)....................................................................................................11
2.7 Electromagnetic compatibility (EMC) ......................................................................................12
2.7.1 Warning and Safety Precautions for Electromagnetic Compatibility ........................................ 13
2.8 Protection against ionizing radiations........................................................................................15
2.9 Laser light source ......................................................................................................................15
2.10 FPD,warnings and precautions..................................................................................................16
2.11 Labeling.....................................................................................................................................17
3MAINTENANCE, CLEANLINESS AND DISPOSAL...................................................20
3.1 Periodic maintenance.................................................................................................................20
3.2 Regular checks performed by the user.......................................................................................20
3.2.1 Obligations for the user............................................................................................................. 20
3.2.2 Repairs ...................................................................................................................................... 20
3.3 Cleaning and disinfection..........................................................................................................21
3.4 Disposal.....................................................................................................................................22
4COMPONENTS IDENTIFICATION...............................................................................23
4.1 Usability ....................................................................................................................................23
4.2 Overview ...................................................................................................................................24
4.3 Safety devices............................................................................................................................25
4.4 Collimator..................................................................................................................................25
4.5 Movements................................................................................................................................25
4.6 X-ray generator control panel....................................................................................................26
4.7 Display ......................................................................................................................................27
4.8 Light signals ..............................................................................................................................27
4.9 Acoustic signals.........................................................................................................................27
4.10 "Digital Imaging System" operating screen...............................................................................28
4.10.1 DeLuxe...................................................................................................................................... 28
5MESSAGES.........................................................................................................................29
5.1 Digital Imaging System signal and messages............................................................................31
5.1.1 DeLuxe...................................................................................................................................... 31
6TRANSPORT......................................................................................................................32
7OPERATION......................................................................................................................33
7.1 Start up ......................................................................................................................................33
7.2 Digital Imaging System switching ON......................................................................................35

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7.3 Positioning.................................................................................................................................36
7.4 Exposures ..................................................................................................................................37
7.5 Exposures in DR mode..............................................................................................................37
7.5.1 DeLuxe...................................................................................................................................... 37
7.6 Exposure in APR "digital" mode...............................................................................................38
7.6.1 DeLuxe...................................................................................................................................... 38
7.7 Exposures in CR mode..............................................................................................................39
7.7.1 DeLuxe...................................................................................................................................... 39
7.7.2 Free exposure............................................................................................................................ 39
7.7.3 Exposures in Programmed Anatomic mode (APR)................................................................... 39
7.7.4 APR data table........................................................................................................................... 41
7.8 Operation mode.........................................................................................................................43
7.8.1 After the exposure..................................................................................................................... 45
7.8.2 DeLuxe...................................................................................................................................... 45
7.9 Optional: radiography with examination table or Potter Bucky grid.........................................46
7.10 Optional : DAP meter................................................................................................................47
7.11 Use end......................................................................................................................................48
8TECHNICAL SPECIFICATIONS ...................................................................................49
8.1 Electrical data............................................................................................................................49
8.2 Environmental conditions..........................................................................................................49
8.3 Total filtration of the equipment................................................................................................49
8.4 Mechanical data.........................................................................................................................50
8.5 Operation data ...........................................................................................................................52
8.6 Radiological data.......................................................................................................................53
8.6.1 kV-mAs relationship ................................................................................................................. 53
8.7 X-ray group ...............................................................................................................................54
8.7.1 Monobloc.................................................................................................................................. 54
8.7.2 X-ray tube ................................................................................................................................. 55
8.8 Collimator..................................................................................................................................56
8.9 Wireless Flat Panel Detector .....................................................................................................57
8.10 Wired Flat Panel Detector .........................................................................................................60
8.11 Pediatric wireless Flat Panel Detector.......................................................................................62
8.12 Digital Imaging System.............................................................................................................63
8.12.1 Software features....................................................................................................................... 63
8.12.2 Hardware specifications............................................................................................................ 64
8.13 Optional: DAP Meter ................................................................................................................65
8.14 Optional: Exposures remote control..........................................................................................66
8.15 Labels ........................................................................................................................................67
9ANNEXES ...........................................................................................................................68
9.1 Replacement of the wireless FPD panel battery........................................................................68
9.1.1 Detector model DRX-1 ............................................................................................................. 68
9.1.2 Detector model 3543 EZ ........................................................................................................... 69
9.1.3 FDX3543RPW model ............................................................................................................... 70
9.1.4 Battery Charger......................................................................................................................... 70
9.2 Protectio box for FPD panel (optional) .....................................................................................71
10 CONFIGURATIONS AND ACCESSORIES...................................................................72
11 DOCUMENT STATUS......................................................................................................74

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1CREDITS
1.1 Compliance
This medical device is in compliance with the Medical Device Directive 93/42/EC
and its revised versions.
The medical device, hereafter called equipment, has been classified in class IIb
according to annex IX rule 10 of the directive mentioned above.
1.2 Manufacturer
The Manufacturer (according to MDD 93/42/EC and its revised versions) of the equipment is:
Villa Sistemi Medicali
Via delle Azalee, 3
20090 Buccinasco, MI (Italy)
Tel.: [phone]
Fax: [phone]
e-mail: [e-mail]
Information about the compliance can be required to the Manufacturer.
1.3 Distributor
The Distributor of the equipment is:
Villa Sistemi Medicali
Via delle Azalee, 3
20090 Buccinasco, MI (Italy)
Tel.: [phone]
Fax: [phone]
e-mail: [e-mail]
1.4 Publishing details
Published by the Manufacturer.
The Manufacturer reserves the right to modify this User's Manual and the equipment here described.
The equipment specifications are subject to variations without notice. Nothing written in this User's Manual
can be considered as an offer, warranty, promise or contractual condition, nor should it be so.
1.5 Copyright
Translations from the original instructions in Italian language.
No part of this User's Manual may be reproduced or transmitted in any form without permission in writing
from Manufacturer.
The software included in the equipment belongs to the Manufacturer. Upon receipt of the equipment, the user
acquires only the right to use the software.
This right is neither exclusive nor transferable.
It is also necessary to seek a written permission to the Manufacturer before making changes for the use of the
equipment for purposes other than those established.

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1.6 Information about User's Manual
The purpose of this User's Manual is to provide a valid help in order to ensure a safe and efficient use of the
described equipment to the users.
Before starting up the equipment, it is necessary to read the User's Manual, note down and strictly respect all
the notices indicating Warning and Precaution messages.
Pay particular attention to information and procedures in the paragraph " Safety".
User's Manual is an integral part of the equipment. It must be kept near the equipment, so that it is possible to
consult it at any minute.
A WARNING message indicates a potential serious outcome, critical event or safety risk. The
missing observation of a warning can cause death or serious injuries to the user and to the patient.
This equipment generates ionizing radiations. Before proceeding with x-ray exposure make sure that
the necessary safety measures against radiations have been adopted
A PRECAUTION message indicates where it is necessary a particular attention to ensure a safe and
efficient use of the equipment. The non-observance of a precaution message can cause slight or
moderate personal injuries, damages to the equipment or to other goods, and expose to a possible
remote risk of more serious injury and/or environmental pollution.
This indication signals particular suggestions, for example to help the user or to improve an
operative sequence.
(A)
Reference to position in the figure.
"EMERGENCY BUTTON PRESSED"
Display messages are in capital letters, italics, and
quoted.
In the figures/photos, the messages are displayed in
English language, while in the text there is their
translation in the language of the manual.
1. Perform visual checks
2.Switch on the equipment
3. Switch on the collimator
Operations that must be done step by step following
the logical numbering order.
Even a sequence consisting of a single step is
numbered
The User's Manual describes the most complete equipment configuration with the highest number of options
and accessories.
Depending on configuration, further use instructions can be supplied together with the equipment. These
instructions must be consulted for information about safety, calibration, test procedures and maintenance.
The User's Manual respects the equipment specifications and it is in compliance with all safety norms
applicable at the date of publication.
The Manufacturer reserves the right to make changes according to technical progress.

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1.7 Compatibility
The equipment described in this User's Manual mustn't be used together with other products or components,
except in case they are explicitly indicated as compatible by the Manufacturer.
A list of these products and components is available by the Manufacturer.
Equipment changes and/or additions must be performed by the Producer or by any third party explicitly
authorized by the Manufacturer.
These changes and/or additions must be in compliance with all effective laws and local rules and must be
performed with the highest technical capability.
Equipment changes and/or additions performed by not properly skilled people and/or by people who
use not approved spare parts, can nullify the equipment warranty.
As for all complicated technical products, maintenance performed by not qualified people and/or by
people who use not approved spare parts can cause serious damages to the equipment and personal
injuries risks.
1.8 Training
Equipment users must be properly trained for a safety and effective use before trying to start up the equipment
described in this User's Manual.
Contents of the training for this type of equipment are different in every country,
It is up to users to be sure to have received a proper training in compliance with effective laws and local
norms.
1.9 Use destination
The equipment is a mobile system used for diagnosis and x-ray examinations in radiography.
The use of the equipment is reserved exclusively to qualified, trained personnel informed about the risks
linked to the use of ionizing radiation.
Its use in professional health service, such as consulting rooms, clinics, hospitals (emergency, patients room,
intensive care, surgery rooms,.. ) is oriented to:
•Radiology
•Intensive care unit
•Hospitalization
•Emergency unit
•Plaster room
•Pediatrics
•Orthopaedics
•Operating theater
•Sports medicine

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2SAFETY
2.1 Warnings and precautions
Maintenance and defects
Do not use the equipment for any application before the user correctly performs all regular checks
and updates the periodical equipment maintenance. If it is sure ( or probable) that any part of the
equipment is defective or wrong adjusted, don't use it before performing all reparations.
The use of an equipment with defective parts or adjusted in a wrong way, can expose the user or the
patient to ionizing radiations or to other dangers concerning safety. This can cause serious or mortal
physical injuries, or wrong diagnosis or therapies.
Importance of safety
Do not use the equipment for any application before reading, understanding and assimilating all
information about safety, safety and emergency procedures specified in the current chapter about
Safety, The use of the equipment without a proper knowledge of safety rules can cause serious or
mortal physical injuries, or wrong diagnosis or therapies.
Proper training
Do not use the equipment for any application unless you have a proper and adequate training to a
safe and efficient use.
If you aren't sure to be able to use this equipment in a safe and efficient way, don't use it. The use of
this equipment without proper and adequate training can cause serious or mortal physical injuries or
wrong diagnosis or therapies.
Do not use the equipment with the patients if there is no adequate understanding of its capabilities
and functions. Using the equipment without an adequate knowledge of its functioning can
compromise the efficacy and/or reduce the safety of the patient, the user and other people nearby.
Safety systems
Never try to remove, modify, exclude or obstruct any safety device on the equipment. An
intervention on safety devices can cause serious physical injuries or even death.
Expected use and compatibility
Do not use the equipment for purpose other than those for which it is intended. Do not use the
equipment with other products than the ones whose compatibility has been recognized by the
Manufacturer. The use of the equipment for purposes other than the ones expected or with an
incompatible product, can cause serious or mortal physical injuries or wrong diagnosis or therapies.
This equipment must be used only in compliance with the safety instructions specified in this User's
Manual and exclusively for intended purposes.
It is user's responsibility to ensure that effective norms concerning installation and use of medical equipment
are respected.

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The Manufacturer is responsible for safety features of its own products, only provided that
maintenance, repairs and modifications are performed exclusively by the Manufacturer's personnel
or by personnel expressly authorized by the Manufacturer.
As for all technical equipments, even this medical device must be used properly and subject to
regular maintenance and care, as described in " Maintenance, cleaning and disposal" paragraph.
The Manufacturer can't be considered responsible for any error, damage or injury caused by
improper use or lack of maintenance of the equipment.
It is necessary to contact the assistance service authorized by the Manufacturer even in the case no
error messages are displayed, but the equipment doesn't work as usual ( first symptoms of a fault).
Do not modify or remove in any way the safety circuits.

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2.2 Electrical Safety
This equipment is in compliance with safety class I, Type B, in accordance with IEC 60601-1 norm.
Do not use the equipment near or leaned against other equipments.
Do not remove protections or cables from this equipment, unless it is expressly required in this
User's Manual, because inside it there are dangerous electrical voltages. The removal of protections
or cables can cause mortal injuries or serious damages to the people.
Protections or cables must be removed only by qualified and authorized technical personnel. Use the
equipment only in rooms or areas comply with all applicable laws ( or regulations having the force of law),
referring to electrical safety of this type of medical device.
Always insulate the equipment from the power supply before proceeding with cleaning or disinfection
operations in order to avoid electric shocks.
Equipotential earth connection
The equipment is supplied with an equipotential earth connection point.
The equipment can be used only in areas comply with local electrical safety norms and in environments
suitable for medical activities. Besides IEC 60601-1 norm provides instructions about the equipotential earth
connection point.
Additional equipotential earth connection
An additional equipotential earth connection is provided because the equipment is movable and the reliability
of the main equipotential earth connection point can be insufficient.
It is possible to use this equipment only in rooms comply with IEC norm requirements.
The equipment described isn't protected against liquids seepage. Its classification is IPx0.
2.3 Mechanical safety
Be sure that parts of the body or clothes aren't stuck among moving components of the equipment.
Remove all objects from range of motion of the equipment.
Check that the unused hanging components ( monitor and radiogenic complex) are positioned so as
not to affect neither the user nor the patients.
It is not possible to transport this equipment while it is working. For a safety transport, switch off
the equipment before transporting it and ensure that all system peripherals ( monitor, mouse,
keyboard, cables etc.) are disconnected.
Do not remove protections or cables from this equipment, unless this operation is expressly
requested in this User's Manual.
The equipment includes moving parts. The removal of protections can cause serious or mortal
physical injuries to people.

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2.4 Protection against explosions
This device mustn't be used in presence of explosive gas or fumes, such as some kind of gaseous
anesthetics. Do not use disinfectant spray flammable or potentially explosive. The use of this
equipment in an unsuitable environment can cause fires or explosions.
2.5 Fire safety
• Do not use this equipment in areas where there is a risk of fire.
• Do not cover the ventilation openings while the equipment is turned on.
• For electrical or chemical fires use only fire extinguisher marked as suitable for such uses. The use
of water or other liquids in an electrical fire can cause physical injuries or even death.
• Before trying to extinguish the fire, the safety measure to be taken is to separate the equipment
from other electric power sources and from all other sources in order to reduce the risk of electrical
shocks.
2.6 Electrostatic discharge (ESD)
Always resort to static procedures, protections and appropriate products before opening or during
the handling of the equipment. This equipment includes electrostatically sensitive components.
Non-compliance with ESD procedures may cause damages to the components. Such damages to the
components are not covered by any warranty.
The electrostatic discharge (ESD) can cause a remarkable voltage that could cause damages to printed circuit
boards (PCB) or to other equipment components.
Electrostatic discharge (ESD) damages can accumulate and can initially not be visible, such as a hardware
failure, but can reduce performances. Therefore, it is recommended to use proper ESD handling procedures.
ESD can be due to low humidity or to the use of electrical equipment on carpets, bedding and clothes.

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2.7 Electromagnetic compatibility (EMC)
This equipment complies with international and national laws and regulations relating to electromagnetic
compatibility (EMC) in force for this type of product, if it is used for the intended purposes. Such laws and
regulations define the electromagnetic emissions level coming from the product and the requested immunity
against electromagnetic interferences from external sources. Other electronic products that exceed the limits
defined by EMC standards can, in unusual situations, affect on the equipment working.
•Electromedical products request special precautions referring to electromagnetic compatibility
(EMC) and must be installed and started up in compliance with EMC information provided in the
documentation enclosed.
•The use of accessories and cables other than those specified can cause a higher emission or lowest
immunity levels.
•The equipment mustn't be used in proximity of other products or stacked on them and, if this will be
necessary, you must check the right functioning.
Mobile phones and laptops
Communications among RF portable and mobile equipments can affect medical equipments. It is
recommended to use caution while using such communication devices within the specified radius of
electromedical devices

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2.7.1 Warning and Safety Precautions for Electromagnetic Compatibility
Increased emission or reduced interference immunity.
Use of unsuitable accessory or lines
►Exclusive use of the listed accessory or line with the exception of internal original spare part
components.
Electric medical units are subject to special precautionary measures with regard to EMC and may only be
installed and put into operation in compliance with the EMC information contained in the Operating Manual.
Portable and mobile radiofrequency communication devices can influence electric medical devices

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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 equipment, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.

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2.8 Protection against ionizing radiations
This equipment generates ionizing radiations ( hereinafter called radiations).
Before proceeding with x-ray exposure, be sure that all safety measures in protection against
radiations have been taken.
While using the equipment, the examination room personnel have to respect all necessary protection
rules. In this context, please observe the following rules:
● To protect patients from radiations, use tools suitable for protection against radiations, as well as
the devices supplied together with the x-ray equipment ( for example, diaphragm, spacer, filter)
● Always wear protective clothing. Anti-radiation clothing with an equivalent of 0,35 mm of lead
can reduce the 99,84% of radiations at 50 kV and the 91,2% at 100 kV.
● If it is necessary to stay in the controlled area, please wear a personal dosimeter. The
Manufacturer suggests to define the personal dose that occurs in the workplace under practical
conditions and to use it as basis for precautions against radiations.
● Distance represents the more efficient protection against radiations. Please keep the largest
possible distance from the exposed object and from x-ray complex.
● Avoid to work in the direct irradiation area; if it isn't possible, please protect yourself, Wear
gloves for protection against radiations.
● Always use the lowest collimation of the x-ray area. Check that interested area is completely
exposed. The diffused radiation depends largely on the volume of the object exposed.
● Always check that the x-ray field collimation completely covers the measurement range selected.
● Always select the largest possible distance between focal point and skin in order to minimize the
dose absorbed by the patient.
● Always select the shortest examination time, in this way the radiation dose is considerably
reduced.
● Move the interested area as close as possible to the image intensifier/ cassette / detector.
Radiations exposure is reduced and even optimized.
● Always keep in mind that any material interposed along the path of radiation between the patient
and the image receiver ( for example film) reduces the images quality and increases the dose
absorbed by the patient.
● Always check that there is visual and audible communication between the user and the patient
during all the examination. If necessary keep the communication using technical means such as an
intercom.
● Do not modify or remove safety circuits that under certain conditions prevent the x-ray emission.
2.9 Laser light source
Laser radiation
Radiations potentially dangerous for skin and eyes.
►Do not stare directly or through optical instruments at the laser beam
►Do not point the laser beam on the face/eyes of the patient

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2.10 FPD,warnings and precautions
Risk of damages to people
Anomalous use of the FPD component.
►Don't use the component for uses other than those foreseen.
►Don't use the component as main shield against x-rays.
Risk of damages to FPD component
The FPD component has internally some shock sensors that allow to know when the shock is
occurred and the type.
If the shock exceeds precise values, the component must be readjusted or returned to factory for the
repair if the shock level is excessive.
►Don't let fall the FPD component.
►Handle with care.
Risk of damages to FPD component
The FPD component is not a patient support device.
It must be placed on a suitable surface, such as a table or the floor, before applying the patient
weight to the component.
►Observe the limitations on the max. weight concentrated on a small area of the FPD surface.
►Observe the limitations on the max. weight divided uniformly on the whole FPD surface.
The limitations on the weight are indicated in the technical specifications of every single FPD panel.
Hot surfaces.
During the standard use the surfaces of the FPD component become hot because of the dissipation
of the component power.
The temperature increases according to the image acquisition frequency.
Inside the component there are some temperature sensors whose value is indicated in DIS user
interface.
If the internal temperature of the FPD panel exceeds the value for every specific panel, switch OFF
and let cool the component.
►Don't use the FPD component to supply heat to the patient.
►Don't exceed the temperature limits indicated for every single FPD component.
►Don't leave the FPD component near heating sources.
Before using the FPD component, read carefully the relative User's Manual attached to the
equipment.

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2.11 Labeling
(A) Equipotential node
(B) Potter connections
(C) Connection of hand switch for exposures
(D) Magnetothermic switch
(A) Label for the monobloc rotation lock.
By rotating the knob clockwise, the rotation stops.
(A) Label for the parking brake lock.
By moving the lever of the brake in horizontal position,
the parking brake is deactivated.
Label present also on the other side of the
equipment.
(A) Label for the obstacles overcoming.

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(A) Label for the movement position of the equipment.
(A) Label for the movement position of the equipment
(B) Label for the exposure hand switch
(A) Laser openings
(B) Warning labels
Avoid the exposure
Radiations are emitted
from this opening
(A) Laser radiation symbol
(B) Warning label:
LED Radiation
Risk group 2 IEC 62471:2006
CAUTION: Do not stare at operating light source.
May be harmful to the eyes.

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(A) Laser radiation symbol
(B) Warning label:
Laser Radiation
Do not stare into beam
Class 2 LASER product
IEC 60825-1:2007
Po ≤ 1mW; λ = 645 ±10nm

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3MAINTENANCE, CLEANLINESS AND DISPOSAL
3.1 Periodic maintenance
For this equipment it is necessary : a correct operation, a periodic maintenance and checks that the user must
regularly perform and that are essential for the equipment to work safely, efficiently and reliably.
Periodic maintenance plan
The periodic maintenance can be performed only by trained and authorized personnel and it is widely
described in the service documentation.
3.2 Regular checks performed by the user
3.2.1 Obligations for the user
The user of the equipment must perform the program of regular checks. Such checks are described in the table
below.
The user of the equipment must ensure that all checks and their actions are performed satisfactorily before
using the equipment for its intended purpose.
Interval
Object
Method
Daily
Defective lights, components, nameplates and damaged warning
signals, main cables and connectors
Check
Daily
All cable and connectors (damage/breaking).
Lack of oil and unusual noises in high voltage generator.
Check
Weekly
Check the locking and braking systems.
Check
3.2.2 Repairs
The equipment includes mechanical parts subjected to wear because of working.
The correct adjustment of electromechanical and electronic complexes affects the working, image quality,
electrical safety and the exposure of the patient and the medical personnel to radiations.
The Manufacturer recommends that repairs must be performed by trained and authorized service
personnel.
Defective components must be replaced with original spare parts.