IMS S.r.l. All rights reserved.
No part of this manual can be reproduced, transmitted, transcribed or filed in a retrieval system or
translated into other languages in any form with any means without written consent from IMS S.r.l.
The buyer may reproduce copies for personal use.
This manual is considered an integral part of the equipment. It must be immediately replaced with
another copy if any part of it is ruined or illegible.
Before performing any type of operation on the equipment, IMS S.r.l. requires that anyone of any
title involved in using the equipment carefully read the entire contents of this manual, paying
special attention to the important warnings.
IMS S.r.l. may not be held responsible for the improper use of the equipment, and for damages
caused by unreasonable operations.
The equipment must only be used to meet the needs for which it was expressly designed. Any
other improper use is considered dangerous.
IMS S.r.l. is considered responsible for the equipment only if it is in its original configuration
determined in the design phase. Any modifications to the structure and the equipment’s operating
cycle must by expressly authorized by the IMS S.r.l. Technical Department.
IMS S.r.l. recommends that only original replacement parts be used and therefore cannot be held
responsible for any damages caused after the use of non-original replacement parts.
IMS S.r.l. reserves the right to modify the design and to make marketable improvements without
forewarning customers who already possess similar models.
IMS S.r.l. is considered responsible for the descriptions written in Italian. The translations cannot
be fully verified, therefore if the buyer finds a discrepancy in the text, this person should refer to the
Italian version and possibly contact our Technical Documentation Office, which will make any
necessary changes.
IMS S.r.l. would like to thank you for choosing one of our machines and we are sure that it will fully
satisfy your needs for a long period of time.
The Giotto Class and its accessories are designed and built mammography examination for the
screening in modality of Full-Field Digital mammography (FFDM) and for diagnosis in modality of
Digital-Breast Tomosynthesis (DBT) for breast cancer detection and cannot be used for other
examinations or for purposes other than those specified by the Manufacturer. Its practical use is
therefore exclusively limited to personnel with medical training.
Using the accessory devices Smart Finder and Flexi table the system is able to perform
stereotactic biopsy examination with the optional possibility to perform the examination with patient
in prone position.
CE: 1936
CLASSIFICATION AND COMPLIANCE
REVISIONS OF THE MANUAL
Please comply with that reported in Section 1 - “Safety”.
Carefully read Section 1 - “Safety” before operating the equipment.
MANUFACTURER’S WARNINGS
This product has the CE marking in conformance with the provisions outlined in Annex II of
93/42/EEC of 14 June 1993 concerning medical devices.
The CE marking is only valid for technical medical products/medical devices put on the market
during the validity of the EC directive indicated above.
If modifications are made to the product without our authorization, the declaration will no longer be
valid.
The original version of this manual was drafted in Italian.
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DO YOU HAVE ANYTHING TO REPORT WITH REGARD TO THIS MANUAL?
Your opinion means a great deal to us!
We strive to constantly improve the documentation of our equipment. To help do this, we give you
the opportunity to directly inform us of any need, suggestion or comment relating to this instruction
manual.
Use the following number to send notices via FAX:
• +39 051 846851.
If you prefer to communicate via e-mail, please use this address:
• imstech@imsitaly.com
In this case, please indicate the complete print reference code reported on the third page.
Thank you for your collaboration.
What I would like to report:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
Non-mandatory data
Name _________________________________________________________________________
Hospetal_______________________________________________________________________
City/Country ____________________________________________________________________
E-mail _________________________________________________________________________
Tel./Fax _______________________________________________________________________
Number of Fax pages ____________________________________________________________
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Sections
This manual is made up of various sections, the titles of which are reported in the
heading.
Paragraphs
Every section can have one or more paragraphs, the title of which is reported in
the text below the heading.
Page
numbers
The page footer shows the progressive page numbers.
1. Safety
1.1. Conventions
In order for the manual to be read quickly and rationally, symbols have been employed for
highlighting practical advice, simple information or situations in which great care must be taken.
Said symbols can be found alongside a section of text (and therefore refer only to that text),
alongside a figure (and refer to the subject illustrated in the figure and to the relative text) or at the
top of the page (in which case they refer to all the subjects treated on that page).
Pay maximum attention to the meaning of the symbols: their aim is not to have to repeat technical
concepts or safety warnings and therefore should be considered as proper “reminders”.
Thus, refer to the list of symbols whenever doubts arise as to their meaning. The symbols shown
in the following pages are not found on the device or its accessory parts; they are only present
in this manual. The series of the manuals supplied with the device usually contains some
documents not made up by I.M.S. S.r.l., which could use edition symbols that are graphically
different from the ones shown in this publication. Therefore, it is advisable to consult all the
documents supplied in order to “store” all the subjects for which the symbols themselves have
been used.
It is important not to confuse the edition symbols on the device with the “safety” plates, which are
applied in predetermined points on the device, auxiliary units, etc...
1.1.1. Structure of the manual
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Instruction
Fornisce istruzioni sul corretto utilizzo dell’apparecchiatura.
Questo testo è preceduto da un rombo.
LIST OF
EXPLANATORY
TEXT
–
This text is preceded by a dot.
Divides an instruction or a list into various sub-parts.
This text is preceded by a dash.
REFERENCE
Refers to more detailed instructions reported in another page
of the manual or another document.
This text is marked by an arrow.
NOTE
This is used in two ways:
highlights important safety information, without which there is an
immediate risk
contains a summary of the main information regarding a subject matter
This text is highlighted inside a grey box.
Menu
The names of the menus are in bold type.
WARNING
Firstly, the source of the danger is indicated.
The possible consequences are then reported.
Finally, you are informed on how to avoid the danger.
LIFT ONLY FROM THE TOP
Operations that require the use of qualified personnel and specific equipment, and the
respect of the conditions stated by the Manufacturer and current regulations.
1.1.2. Text formatting
This manual contains certain text formats that are helpful in understanding the function of the text
more quickly.
The following characters were used:
1.1.3. Warning, caustions and information
The icons in a box give information .
The symbols in a triangle are DANGER/WARNING symbols.
The symbols in a circle represent an OBLIGATION/PROHIBITION..
1.1.3.1. Warning
Warnings indicate the possible presence of risks for the health and safety of patients, operators
and third parties.
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CAUTION
Firstly, the source of the danger is indicated.
The possible consequences are then reported.
Finally, you are informed on how to eliminate the danger.
NO!
Operations to be absolutely avoided.
INFORMATION
Il relativo testo è scritto in corsivo dentro il box grigio
EQUIPMENT TURNED OFF
With electrical power supplies isolated
OBLIGATION symbols
Use PROTECTIVE GLOVES
This symbol indicates that the maintenance engineer must wear protection
gloves to avoid injuries.
Use PROTECTIVE GLASSES
This symbol indicates that the maintenance engineer must wear protective
glasses to avoid injuries
PROHIBITION symbols
No MAINTENANCE/REPAIRS ON MOVING MEMBERS
It is forbidden to repair, adjust, clean or lubricate moving members of the
machine
HAZARD/CAUTION symbols
CAUTION: ELECTRIC SHOCK HAZARD
It indicates the presence of electric devices and powered components and
warns the operator against electric shock hazards.
The electric maintenance engineer is the only operator that is qualified to carry
out adjustments or maintenance of the electric cabinets and junction boxes
CAUTION!
It indicates the presence of ionizing radiation.
1.1.1.1. Caution
This indication reports that an incorrect command could cause minor injuries or damage to the
equipment.
1.1.1.1. Information
This indication provides further explanations about an issue.
1.1.1.1. Safety symbols
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SYMBOLS FOR THE MANUALS
THIS OPERATOR MANUAL
Descriptions inherent to this manual.
SUBCONTRACTING MANUALS
Consult the attached documents relating to subcontracting.
OPERATORS
Radiological technician: the person in charge of preparing the equipment,
positioning the patient and performing the mammography examination,
according to the indications given by the doctor.
Doctor: the person who visits the patient in advance in order to decide the
examination method. This person observes the plates taken by the radiological
technician. He/she carries out the invasive operations (biopsy) on the patient.
Mechanical maintenance personnel: qualified technician able to intervene
on the mechanical parts of the equipment to perform any necessary
maintenance interventions and repairs. This person is not qualified to work
on live-electrical circuits.
Electrician: qualified technician able to carry out any necessary interventions of an electrical or electronic nature. This person is qualified to work on live-
electrical circuits.
Manufacturer’s technician: qualified personnel provided by the Manufacturer
to perform complex operations under particular situations or when agreed
upon with the Buyer
1.1.1.1. Manuals symbols
1.1.1.1. Qualification of the personnel in charge with operation of the
equipment
The operators that have access to the equipment must be specifically qualified, trained and
responsible for the tasks they are in charge with.
A description of the professional qualifications of the operators and maintenance personnel is
given below. Each profile is graphically described by an icon.
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INFORMATION
In some figures the equipment may be highly equipped or outfitted with optional
accessories.
INFORMATION
A test report shall be filed in I.M.S. S.r.l. archive.
The names and data of all the patients and devices used in this manual as examples are fictitious.
Any similarity or correspondence to the actual names of people or institutions are purely
coincidental.
All the parameters and images reported in this manual are examples. The parameters seen in your
system are determining factors.
1.1.1. Regulations and laws
If there are regulations with legal implications for the installation and/or use of the device, the
installer and user must respect them. The national standards must be respected in every country.
With the exception of that given in this manual, the values can be set based on the national
standards.
This product has the CE marking in conformance with the provisions contained in directive
93/42/EEC of 14 June 1993 concerning medical devices,
Personal data are protected.
Please respect the regulations pertaining to this matter. During the manufacturing phase, the
equipment is checked according to applicable product standards.
The tests to be performed at the equipment installation site are the responsibility of the customer.
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INFORMATION
After pressing one of these three emergency stop buttons, the following message
appears on the touchscreen panel
and an acoustic signal is simultaneously emitted.
1
2
1.2. Safety systems
1.2.1. Emergency stop buttons
Three emergency stop buttons are installed on the equipment described in this manual. If
pressed, they immediately stop all equipment functions.
1) EMERGENCY STOP button located on both sides of the vertical X-ray unit (GANTRY) near two
columns push-button panels.
2) EMERGENCY STOP button located on control table of the acquisition workstation (AWS).
Never use the emergency stop button as a normal stop device to immediately stop all functions of
the equipment, but only in cases of an actual emergency and if malfunctions occur.
After the EMERGENCY STOP button has been activated, keep in mind the following:
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INFORMATION
The emergency stop button does not cut power to the workstation 1. The workstation
is also protected by an uninterruptible power supply UPS 2. The UPS takes power
from the equipment’s circuit; thus turning on “0” position the main switch, the UPS
switches to the batteries and the operator is informed of this operation by an acoustic
signal.
In the case of a power interruption, only the AWS acquisition workstation is powered
by the UPS for a few minutes (depending on the state of the battery). When the
battery of the uninterruptible power supply reaches 20%, the workstation
automatically turns off, following the operating system’s safety sequence.
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INFORMATION
After pressing one of these three emergency stop buttons, the following message
appears on the touchscreen panel
and an acoustic signal is simultaneously emitted.
1.3. Resuming operation after an emergency stop
Release the pressed emergency stop button by turning it (slightly). The acoustic signal will be
silenced and the alarm message on the touch screen panel will disappear ( see Section 12 -
“Breakdowns and diagnosis”).
To resume operations, press the engage circuits push-button 1 sited on the acquisition
workstation control table switching it to the “OFF” position (LED off). What a few seconds and
then press the engage circuits pushbutton 1 again, switching it to the “ON” position (LED on).
If the cause of the stop has been eliminated, the device will then be operational again.
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1.3.1. Control and signals
The acquisition workstation has a main switch 1, an engage circuits push button 2 and a touch
screen panel 3 that is used to control and monitor the appliance. The touch screen panel displays
set parameters and alarm messages.
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1.4. General Safety precautions
•The device may be dangerous to the patient and operator if the X-ray exposure values and
operating instructions are not respected. Observe all operating and safety instructions before
performing an X-ray exam.
• Check the following before installation: observance of minimal safety regulations, location and
operating efficiency of the equipment, measuring ambient conditions (temperature, humidity and
lighting) and checking the suitability of the work space.
• Always work with suitable clothing and the required personal protective equipment.
• While X-rays are being emitted, the operator must remain shielded behind the X-ray lead glass
panel supplied with the vertical X-ray unit (GANTRY).
1.5. Protection and safety regulation
• The person who is about to activate the radiological device must check that nobody else is in the
room, that the doors are closed and that all those present are protected by walls or by shielded
doors.
• During X-ray emissions, always stay behind the X-ray lead glass panel.
• Whenever necessary, always wear the personal dose-meter.
• Reduce the size of the beam and the value of the radiological parameters to a minimum (voltage,
current and radiography time) in so far as they are compatible with the diagnostic needs.
1.6. Warnings and precaustions
•The following is strictly forbidden: tampering with the equipment, controls and safety devices.
• Any modifications or tampering, however slight. The use of non-original spare parts, or spare
parts that are not compatible with the quality standards and electro-mechanical characteristics
specified by the Manufacturer, shall relieve the Manufacturer of all liability and shall void the
warranty rights.
• It is strictly forbidden to place and/or leave objects or anything else not foreseen by the
Manufacturer on the equipment that is potentially harmful to the safety of persons or the integrity of
the equipment.
• Carefully read the steps in this manual that are marked: “INFORMATION” and “CAUTION”.
• If you have any requests, always indicate the model and serial number of the equipment.
• Access to the workstation is password protected.
• It is forbidden to modify the configuration of the workstation.
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CAUTION!
It is strictly forbidden to operate the equipment if it is not permanently fixed to
the floor. Refer to the relative Section.
Mechanical group
List of screws
Reference draw
• It is forbidden to install software different from the original software that was installed by I.M.S.
S.r.l. service personnel.
• The workstation can be connected to a LAN/WAN network, but the user is responsible for
protecting against viruses, intrusions or data leaks.
•The AWS acquisition workstation TFT monitor can only be used for QA before diagnosis. No
clinical evaluation is allowed.
• Diagnosis can be done both through analysis of laser printed images and the images on the
workstation of reporting workstation (RWS) (optional). The monitor type and performance must comply with the I.M.S. S.r.l. specifications.
• The “DICOM CD” function of the “Raffaello” appliction software is not built for the permanent
filing of data.
This function is only used for data transfer.
• The “Raffaello” application software installed on the AWS acquisition workstation is able to
store a certain number of examinations (the number depends on the capacity of the hard disks).
This archive is not a legal archive, so any lost data is not the responsibility of I.M.S. S.r.l..
1.6.1. Mechanical safety
The assembly procedure of some part of the device can be critical for the functionality of the device
itself and to assure the safety performance of fine movement.
Following the list of screws and bolt must be used for each critical mechanical group.
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CAUTION!
X-ray machines can be extremely dangerous to the patient and the operator if the specified protective measures are not scrupulously observed
1.7. General safety warning
The device was designed and built in compliance with the most severe safety Regulations and left
our production plant in perfect working order. In order to ensure that these conditions are
maintained and that the device is used correctly, the technician must follow the instructions
contained in this manual.
RESIDUAL RISKS
• Although the equipment described in this manual was built in full compliance with the most
severe safety Regulations, the emission of X-rays is a potential hazard and the equipment
therefore cannot be used or handled by unappointed, unqualified, or unauthorized personnel.
• Over-exposure to X-rays can cause serious damage to the human body.
• Although X-ray radiation is in itself dangerous, the GIOTTO TOMO equipment does not cause
any dangerous conditions if used correctly.
• It is therefore essential that all technical and healthcare personnel be suitably informed and
instructed with regard to the hazards of X-ray exposure.
1.8. Radiation protection warnings
• Exposure to X-rays is a health hazard, and therefore great care should be taken in using
adequate means of protection. Radiation can accumulate over time and its effects can be
manifested after many years.
• Primary radiation is the most dangerous kind, therefore, avoid exposure; any object stuck by
primary radiation produces secondary radiation, which is also highly dangerous.
• The unit is equipped with an protective X-ray temperate glass screen coupled to the console,
which protects people against diffused radiation.
1.9. Electrical safety device
• The device must have an electrical supply line equipped with an earth circuit complying to current
Standards.
For any type of simple maintenance, such as cleaning the equipment, always disconnect it from
the mains to avoid damage to persons and/or the electrical - electronic part of the mammography
equipment.
• To ensure the isolation integrity for the system, use only I.M.S. S.r.l. approved accessories on the
equipment. Any changes to the interconnections must be performed by I.M.S. S.r.l. authorized
personnel.
• To ensure proper isolation maintain a 1.5 meter distance between the patient and any
devices not approved for use in the Patient Area. Devices not approved for use in the patient
area (such as the data management computer, the medical recording workstation, laser printers)
must not be installed in this area (see IEC 60601-1-1).
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CAUTION!
In accordance with EN 60601-1, the unit must be permanently connected to
the electrical mains.
(The protective earth conductor must be connected directly to the protective
earth terminal of the electrical panel).
INFORMATION
A test report shall be filed in I.M.S. S.r.l. archive.
1.10. Exsplosion hazard
• Gas or flammable vapors cannot be used with this equipment.
• Some types of disinfectants could vaporize, thus forming an explosive mixture. If used, they must
be allowed to disperse before powering up the equipment.
1.11. Risk associated witj cleaning the device
• Gas or flammable vapors cannot be used with this equipment.
• Some types of disinfectants could vaporize, thus forming an explosive mixture. If used, they must
be allowed to disperse before powering up the equipment.
1.12. X-ray emission safety
The device uses two separate methods to assure that the generator doesn’t exceed the maximum
exposure limit.
a) A software counter that includes the anode current over time and stops the exposure when the
maximum time has been reached; the counter is protected by a watch dog circuit.
b) A hardware counter that cuts off the electrical power supply to the generator if the maximum
allowed exposure time is exceeded.
1.13. Regulations, laws and normative reference
If there are regulations with legal implications for the installation and/or use of the device, the
installer and user must respect them. The national standards must be respected in every country.
With the exception of that given in this manual, the values can be set based on the national
standards.
This product has the CE marking in conformance with the provisions contained in directive
93/42/EEC of 14 June 1993 concerning medical devices,
Personal data are protected.
Please respect the regulations pertaining to this matter. During the manufacturing phase, the
equipment is checked according to applicable product standards.
The tests to be performed at the equipment installation site are the responsibility of the customer.
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Keep the hands away
Radiation
High Tension
Main Identification label
Parts under voltage
Moving part
IPX0 Protection class label
Earth point
Focal Spot
Electrostatic discharge
WEEE Label
Component Identification
2. General Information
2.1. Labels
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2.1.1. Labels on the X-ray unit
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2.1.2. Labels on the operator console (AWS)
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Label
ID
Label
Component
Description
1
IMS accessory
Identification data
2
High-Voltage
Generator
Identification data
3
X-ray tube:
Identification data
4
Focal spot position
2.1.3. Labels on the internal component
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Label
ID
Label
Component
Description
4
Earth point
5
Vertical
movement motor
Identification data
6
Anti-scatter grid
Identification and
specifications data
7
INSERIRE IMMAGINE CON
IDENTIFICAZIONE E HVL
Collimator
Identification and
specifications data
8
Monitor
Identification data
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