IMS M189 Service manual

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SERVICE AND INSTALLATION MANUAL
M189_EN: Draft version_0.1 del 01/07/15
SERVICE AND
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MANUAL
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Index:
1. Safety.................................................................................................... 10
1.1. Convensions ..................................................................................................... 10
1.2. Safety systems .................................................................................................. 15
1.3. Resuming operation after an emergency stop .................................................. 17
1.4. General Safety precautions............................................................................... 19
1.5. Protection and safety regulation ........................................................................ 19
1.6. Warnings and precaustions............................................................................... 19
1.7. General safety warning ..................................................................................... 21
1.8. Radiation protection warnings ........................................................................... 21
1.9. Electrical safety device ..................................................................................... 21
1.10. Exsplosion hazard ............................................................................................. 22
1.11. Risk associated witj cleaning the device ........................................................... 22
1.12. X-ray emission safety ........................................................................................ 22
1.13. Regulations, laws and normative reference ...................................................... 22
2. General Information............................................................................. 23
2.1. Labels ............................................................................................................... 23
2.2. Technical data ................................................................................................... 31
3. Panoramic view of the system ............................................................ 60
3.1. Description of the system .................................................................................. 60
4. Transport and moving ......................................................................... 65
4.1. Contents of the delivery .................................................................................... 65
4.2. Packing characteristic ................................ ....................................................... 65
4.3. Components inside the gantry packing ............................................................. 66
4.4. Components inside the AWS packing ............................................................... 67
4.5. Lifting and moving of packing ............................................................................ 68
4.6. Storage of packed equipment ........................................................................... 69
4.7. Removing the gantry from the pack .................................................................. 71
4.8. Removing the AWS from the pack .................................................................... 72
4.9. Disposal of the packing ..................................................................................... 72
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4.10. Instructions for the handling, storing and packing of digital detector ................. 73
5. Installation ........................................................................................... 77
5.1. Ambient requirements conditions ...................................................................... 77
5.2. Preliminary radiology room inspection .............................................................. 78
5.3. Preliminary mechanical clamping inspection..................................................... 78
5.4. Installation procedure ........................................................................................ 79
6. Preliminary operating check ............................................................... 87
6.1. Checks before using the unit............................................................................. 87
6.2. Initial start-up .................................................................................................... 88
6.3. Troubleshooting before initial start-up ............................................................... 90
6.4. Quality checks before clinical application .......................................................... 92
6.5. Connection to the DICOM ntework ................................................................... 92
6.6. Operator instructions ......................................................................................... 93
7. Method of use ...................................................................................... 94
7.1. Equipment ......................................................................................................... 94
7.2. Acquisizione Work Station .............................................................................. 109
7.3. System Messages ........................................................................................... 114
7.4. Patient Registration ......................................................................................... 115
7.5. Exposure data setting ..................................................................................... 117
7.6. Performing the exposure ................................................................................. 118
7.7. Printing the exam images ............................................................................... 122
7.8. Concluding the exam ...................................................................................... 122
7.9. Manually sending images to other DICOM workstation .................................. 122
8. Image quality assessment ................................................................ 124
8.1. AEC Test for Installation ................................................................................. 125
8.2. Dose Calibration check ................................................................................... 133
8.3. Image Honogeneity and defective element evaluation .................................... 134
9. Components diagnosis ..................................................................... 140
9.1. Geometry of acquisition setting ................................................................ ....... 140
9.2. Detector .......................................................................................................... 141
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9.1. X-ray tube ....................................................................................................... 151
10. Electronic boards .......................................................................... 161
10.1. Electronic boards topographic diagram ........................................................... 161
10.2. I008 – Collimator board ................................................................................... 162
10.3. I009 Compressor board .................................................................................. 163
10.4. I009PB Compressor Piggy Back board ........................................................... 164
10.5. I010 Detector .................................................................................................. 165
10.6. I011 Biopsy board ........................................................................................... 166
10.7. I011AC Biopsy cabling switching .................................................................... 167
10.8. I012 Gantry boards ......................................................................................... 167
10.9. I013 SELEMA actuation .................................................................................. 168
10.10. I014 Gantry keyboard ..................................................................................... 168
10.11. I015 Tube keyboard ........................................................................................ 168
10.12. I017 Wireless foot pedals power board ........................................................... 169
10.13. I020 Power switching board ............................................................................ 169
10.14. I021 Operator control table command board .................................................. 170
10.15. I022 Operator control table Cabling switching board ...................................... 170
11. Maintenance .................................................................................. 171
11.1. Warnings on routine maintenance .................................................................. 171
11.2. Cleaning .......................................................................................................... 172
11.3. Preventive maintenance program ................................................................... 173
11.4. Disposal and scrapping of the obsolete equipment ......................................... 175
12. Breakdowns and diagnosis .......................................................... 176
12.1. Introduction ..................................................................................................... 176
12.2. Alarms management ....................................................................................... 177
12.3. List of alarms ................................................................................................... 180
13. Interventions on the equipment ................................................... 181
13.1. Introduction ..................................................................................................... 181
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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.
IMSS.r.l.
Internazionale Medico Scientifica
Via Sagittario 5 - 40037 Pontecchio Marconi - Bologna - Italy
Tel ++39 051 846851 - Fax ++39 051 846856 e-mail: Export Dept.: imscomm@imsitaly.com
Tecnical Dept.: imstech@imsitaly.com
http://www.imsitaly.com
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IEC 60601-1
Class
I
Type
B
Medical Device Directive 93/42/CE
Class
II B
DOCUMENT N°:
M189_EN
REVISON:
0.1
DATA:
01/07/15
N° REV.
DATE
Purpose of the revisions
Modified PAGES
Modified SECTION
01
01/07/15
Initial release
Intended use
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 equipments 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 systems 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).
M189_EN:Safety Draft version_0.1 del 01/07/15
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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 doesnt 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.
M189_EN:Safety Draft version_0.1 del 01/07/15
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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
M189_EN:General Information Draft version_0.1 del 01/07/15
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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
M189_EN:General Information Draft version_0.1 del 01/07/15
SERVICE AND
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M189_EN:General Information Draft version_0.1 del 01/07/15
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Tel. ++39 051 846851
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