User Manual
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NewTom 5G – User Manual
97050196 Rev. 2.2 01.07.2016
EN
NOTES This document is provided as a consultation manual intended for the device users. QR s.r.l. follows a policy based on the constant development and update of the product. For this reason, it reserves the right to change the content of this manual without prior notice. This document can not be modified, copied, reproduced, distributed, saved on magnetic or optical supports, or published on websites and other on-line services, in full or in part, without the prior written authorisation of QR s.r.l. The original version of this manual is in Italian. NEWTOM™ 5G is a trademark of QR s.r.l. All other products and trade names mentioned in this document are registered marks of the relevant manufacturers. INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES The medical device referred to in this manual consists of a scanner and a control, display and calculation unit (Main Workstation). Such device, as delivered and configured by the production and assistance technical personnel, is an X-ray device compliant with the safety requirements set forth by the Italian Legislative Decree of 19 September 1994, no. 626 implementing Directives 89/391/EEC, 89/654/EEC, 89/655/EEC, 89/656/EEC, 90/269/EEC, 90/270/EEC, 90/394/EEC and 90/679/EEC concerning the improvement of the health and safety of workers in the workplace, and with the essential requirements set forth by the Italian Legislative Decree 24 February 1997, no. 46 implementing Directive 93/42/EEC as amended, on the medical devices. The medical device referred to in this manual is an X-ray device compliant with Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Any tampering with, modification, updating or other change both of hardware 1 and software2 of the device as supplied and installed by the company (and in the conditions specified in the attached documentation) may partially or totally compromise the device expected operation. This may also alter the safety features with consequent hazard increase for patients, operators and surrounding environment. For this reason, should the user need to modify the device, he/she must request a written authorisation by QR s.r.l. Failure to comply with what is specified in this informative note will null and void the device warranty and the civil and/or penal responsibility for any consequent damage and/or accident and/or worsening of the patient, operator or other people health (including the surrounding environment) will be borne by the person who tampered with the device or his/her legal representative.
1 Adding of a new memory expansion, a new hardware on the connection bus, a printer, the replacement of the graphic display interface represents an important modification.
2 Including the operative system and the applications already installed upon medical device delivery. Automatic updates of the operative system, changes to network connection parameters, modification and/or addition and/or removal of interface software with hardware (device driver) and/or services (e.g. file and printer sharing service) and/or applications represent an important modification.
Summary 1 INTRODUCTION TO THIS MANUAL......................................................................1-1 1.1 Contents.......................................................................................................... 1-1 1.2 Structure......................................................................................................... 1-1 1.3 Graphic conventions............................................................................................1-3 1.3.1 Text conventions......................................................................................... 1-3
2 ABOUT SAFETY............................................................................................2-1 2.1 Local law......................................................................................................... 2-1 2.2 Symbols overview............................................................................................... 2-2 2.3 Switching ON and OFF the device.............................................................................2-3 2.4 Emergency stop.................................................................................................. 2-3 2.5 Patient's and user's safety guidelines.........................................................................2-4 2.5.1 Patient's positioning.....................................................................................2-4 2.5.2 During the scan........................................................................................... 2-4 2.5.3 Patient's exit from the scanning area................................................................2-5 2.5.4 Patient's exit during fault / malfunctioning of the patient's table..............................2-5 2.6 Artifacts and repetition of a scan.............................................................................2-6 2.7 Protection from ionizing radiation............................................................................2-7 2.8 Protection from laser exposure...............................................................................2-9 2.9 Devices connected to the NewTom 5G console ...........................................................2-10 2.10 Maintenance time lag........................................................................................2-10
3 SAFETY AND MAINTENANCE OF THE DEVICE.........................................................3-1 3.1 Installation requirements......................................................................................3-1 3.2 Guidelines for safety........................................................................................... 3-2 3.3 Device modifications...........................................................................................3-3 3.3.1 Responsibility limits.....................................................................................3-3 3.4 Device maintenance............................................................................................ 3-3 3.5 Cleaning and disinfection......................................................................................3-5 3.5.1 Chemical agents to avoid...............................................................................3-5 3.5.2 Cleaning................................................................................................... 3-6 3.5.3 Disinfection............................................................................................... 3-6 3.5.4 Sterilization.............................................................................................. 3-6 3.6 Transport and storage..........................................................................................3-6 3.7 Device disposal.................................................................................................. 3-7 3.7.1 Information for the device owner.....................................................................3-7 3.7.2 Information for the Disposing/Recycle centers.....................................................3-7 3.8 Biocompatibility.................................................................................................3-7
4 GETTING STARTED........................................................................................4-1 4.1 Introduction to the system....................................................................................4-1 4.1.1 Intended use.............................................................................................. 4-1
4.1.2 Indications for use.......................................................................................4-1 4.1.3 Improper Use............................................................................................. 4-2 4.1.4 Device Operation........................................................................................4-3 4.2 Working principle................................................................................................4-3 4.3 Overall view...................................................................................................... 4-4 4.3.1 Control panels............................................................................................ 4-5 4.3.2 Patient table console...................................................................................4-6 4.3.3 Patient table with stretcher console.................................................................4-8 4.3.4 Input panel and main switch.........................................................................4-10 4.4 Standard accessories.......................................................................................... 4-10 4.4.1 Cables.................................................................................................... 4-11 4.4.2 Optional accessories...................................................................................4-11 4.5 System start-up................................................................................................ 4-12 4.6 System shut down.............................................................................................. 4-12
5 PRELIMINARY PROCEDURES.............................................................................5-1 5.1 X-Ray Source Conditioning.....................................................................................5-1 5.2 Daily Check....................................................................................................... 5-3 5.3 Blank acquisition................................................................................................ 5-4 5.3.1 Invalidating the Blank acquisition.....................................................................5-5 5.4 Beam limiter test...............................................................................................5-6
6 SCANNING...................................................................................................6-1 6.1 Patient scan...................................................................................................... 6-2 6.1.1 Patient preparation.....................................................................................6-2 6.1.2 Positioning the patient and starting a new scan....................................................6-4 6.1.2.1 Patient positioning with patient table.....................................................6-6 6.1.2.2 Patient positioning with patient table with stretcher...................................6-9 6.2 Scanning a denture............................................................................................ 6-13 6.2.1 Preliminary operations and denture positioning..................................................6-13 6.2.1.1 Denture positioning with patient table...................................................6-13 6.2.1.2 Denture positioning with patient table with stretcher.................................6-14
7 QUALITY ASSURANCE.....................................................................................7-1 7.1 Phantom positioning............................................................................................7-1 7.2 Images samples.................................................................................................. 7-4 7.3 Storage of QA data.............................................................................................. 7-5
8 TROUBLESHOOTING.......................................................................................8-1 9 IEC61223: ACCEPTANCE TEST..........................................................................9-1 10 APPENDIX A- TECHNICAL REFERENCES.............................................................10-1 10.1 Scanner........................................................................................................ 10-1 10.2 Detector....................................................................................................... 10-2 10.3 Scout view radiological images.............................................................................10-3 10.4 Reconstructed volume ......................................................................................10-4 10.5 Radiological parameters.....................................................................................10-6
10.5.1 X-Ray Tube IAE model X22 0.3/0.6 ................................................................10-6 10.5.2 X-Ray tube head.....................................................................................10-11 10.5.3 X-Ray source assembly..............................................................................10-12 10.6 Inverter....................................................................................................... 10-13 10.7 Dose declaration............................................................................................ 10-14 10.8 Stray radiation diagram....................................................................................10-22 10.9 Laser.......................................................................................................... 10-23 10.10 Other data..................................................................................................10-23 10.11 Electromagnetic compatibility..........................................................................10-24 10.11.1 Essential performance.............................................................................10-28
11 APPENDIX B – SECURITY STANDARDS...............................................................11-1 12 APPENDIX C - LABELS.................................................................................12-1
1 Introduction to this manual
1
Introduction to this manual
1.1 Contents This manual was created as a mean to provide information and instructions about using a NewTom ™ 5G device. This manual comprises all versions of the series (NewTom 5G, NewTom 5G version FP), in the following generically called “NewTom 5G”. NewTom 5G series devices are distributed under QR or NewTom brand. Dedicated software routines (scan, data processing, reporting, document management) and their user instructions are described in the “Acquisition Operations with NewTom VGi-5G” annex to the “NNT User Manual” document. "User Manual", "NNT User Manual" and “Acquisition Operations with NewTom VGi-5G” should be read and clearly understood in every part before starting using the device. It is suggested to store this manual along with any other documentation and to use it whenever a new staff member has to be trained for using the device.
1.2 Structure This manual is divided in the following chapters: ✔
Chapter 1: Introduction to this manual Provides information about contents, structure and conventions inside the document.
✔
Chapter 2: About safety Provides information about user's and patients' safety and primary procedures regarding the use of the device.
✔
Chapter 3: Safety and maintenance of the device Provides information about safety requirements and the device maintenance.
✔
Chapter 4: Getting started Gives an overall description of the system and of its main parts.
✔
Chapter 5: Preliminary procedures Illustrates the procedures for a proper initialization of the device.
✔
Chapter 6: Scanning Describes the process for patient and prosthesis's positioning and scanning.
✔
Chapter 7: Quality assurance Gives instructions about the execution of the Quality Assurance process in order to verify the image
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1 Introduction to this manual quality.
1-2
✔
Chapter 8: Troubleshooting Provides information about possible faults of the device and their solution.
✔
Chapter 9: IEC61223: Acceptance Test Provides procedures for testing as required by IEC61223 standard.
✔
APPENDIX A- Technical references Provides the technical reference of the device.
✔
APPENDIX B – Security standards Lists the standards conformity of the device.
✔
APPENDIX C - Labels Lists the labels of the device.
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1 Introduction to this manual
1.3 Graphic conventions Primary information about safety and possible notes are highlighted by the following symbols: DANGER: Alerts for a potential danger which may cause injury or death of a person. WARNING: Signals the presence of a potential danger which may damage the device. NOTE: Provides information not related to the device and/or the user's and/or the patient's safety. IMPORTANT: Instructions that you MUST follow to complete a task.
1.3.1 Text conventions
Bold text
Indicates a menu or an item to select
Italics
Used to emphasize a word or a phrase
<Key>
Key enclosed in the less-than and greater-than sign means that you must press the enclosed key.
<Key1+Key2>
If you must press two or more keys simultaneously, the key names are linked with a plus sign (+) Example: <Ctrl+Alt+D>
Command
NewTom 5G – User Manual
Means that you must type the command exactly as shown.
1-3
2 About safety
2 This chapter includes information about safety NewTom 5G device.
About safety
to which the user should be familiar before using the
In order to ensure the patient and user's safety, the operator must follow the instructions included in this manual, particularly for the functional tests, the electrical and mechanical safety and for the protection against ionizing radiations exposure. For these guidelines, please refer to the current chapter, to Chapter 3 - “Safety and maintenance of the device“ and to Chapter 6 - “Scanning“. WARNING: All the operators must be familiar with the operating and environment features of the equipment and have indepth knowledge of the procedures to follow in case of danger or in case an emergency shut down of the device is required.
2.1 Local law Carefully follow every requirements about installation and maintenance of the device. Please refer to the local laws whenever these may be more strict than the instructions inside this manual.
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2 About safety
2.2 Symbols overview The table below describes the symbols found on the device labels: Symbol
~
Standard IEC 60417-5010
ON / OFF (push-push)
IEC 60417-5032
Alternating current
ISO 7000-0434A
Caution
ISO 7010-W001
General warning sign
IEC 60878 ISO 3864-B.3.6
Warning: dangerous voltage
IEC 60417-5019
Protective earth (ground)
IEC 60417-5017
Earth (ground)
N
IEC 60445
Connection point for the neutral conductor on permanently installed equipment
L
IEC 60445
Connection point for the line conductor on permanently installed equipment
IEC 60417-5841
ISO 361
Directive 2012/19/EU
Directive 93/42/CEE
2-2
Description
Defibrillation-proof type B applied part
Ionizing radiations
Disposal of WEEE (Waste from Electrical and Electronic Equipment)
CE Mark
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2 About safety EN 980:2008
Serial Number
EN 980:2008
Date of manufacture
EN 980:2008
Manufacturer
ISO 7000-1641
Operating instructions
ISO 7010-M002
Refer to instruction manual/booklet
IEC 60417-5638
Emergency stop
2.3 Switching ON and OFF the device Turning the device ON and OFF must be performed according to the procedures described in Chap. 4.5 “System start-up” and 4.6 - “System shut down”.
2.4 Emergency stop The device is supplied with 4 emergency buttons. The first button is installed close to the operator table. The second button is located on the patient's table below the table control panel. Two additional buttons are placed on the side of the scanner gantry next to the control panels.
Figure 1: From left : Emergency button on the operator's table, on the patient's table, on the scanner
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2 About safety
Switching off the device through an emergency button will result in a prompt break of the x-ray emission and in an interdiction of all the motor movements. WARNING: The emergency buttons must be used only in a danger situation, such as:
•
The X-Ray source does not stop emitting;
•
Dangerous conditions that may damage people, the environment or the device;
•
Whenever the system signals an emergency state.
2.5 Patient's and user's safety guidelines Risks for patients and for involved people are avoided working in a proper way and correctly positioning the patient. Special care should be taken in case of disabled or injured people.
2.5.1 Patient's positioning Be sure that a patient is properly placed inside the scan area, with his/her head on the head support, and that no part of his/her body may impact the device or be pressed during the positioning and the examination. Be sure that a patient's garments and hair may not get caught. Similarly regarding catheters and ECG cables. Do not perform any movement until the patient's safety is assured and there are no obstacles to the device movement. For additional information about positioning the patient, refer to Par. 6.1.2 - “Positioning the patient and starting a new scan“.
2.5.2 During the scan NEVER leave the system without a supervisor during the positioning of the patient and the execution of an exam. Always watch the patient all along the scan process. WARNING: Never use the device without the supervision of an operator.
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NOTE: Please consider the realization of an audio/video communication system between the operator and the patient, especially when the operator controls the device from a protected and remote location.
2.5.3 Patient's exit from the scanning area At the end of an exam or after an emergency shutdown, the patient can be extracted from the scan area and can walk away from the scanner.
2.5.4 Patient's exit during fault / malfunctioning of the patient's table In case of patient table malfunctioning, act on the manual release to take out the patient from the gantry, and operate as follows:
In case of patient table with stretcher malfunctioning, manually remove the patient from the gantry by sliding the stretcher completely out (for more details about this procedure please refer to Par. 6.1.2.2)
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2 About safety
Here are some general guidelines for the extraction in case of disabled patient or unconscious: 1. Get help from other people. Three person are required. Two people on each side of the patient and a third person to check and help the movements of the patient head. 2. On each side of the patient, place one hand under the patient's shoulder and the other under the patient's pelvis. 3. Remove the head support from the gantry and hold up the patient's head. 4. Gently, slide the patient out of the gantry verifying the patient's head is safely supported. 5. If possible, ask the patient to collaborate during the procedure in order to facilitate the entire process. Operator's guidelines during the aforementioned process: ✔ ✔ ✔ ✔ ✔ ✔
Avoid to flex the back, by bending the knees; Increase the support area by enlarging and bending the legs transversely or longitudinally depending on the direction of the movement. Get close to patient as much as possible; Ensure a good hand grid on the patient before starting any movement; During the process impart the necessary indications through words, single phrases and gesture. Do not lift the patient. NOTE: For additional movement of the patient toward a stretcher, a wheelchair or a different device, in case of unconscious or ambulant patient, please refer to the standard procedures.
NOTE: In case of involuntary power supply interruption, the maximum vales of the distance of motorized patient table movements (with a maximum rated load applied) are the following: Longitudinal Movement: <5mm Transversal Movement: <10mm Vertical movement: <5mm
2.6 Artifacts and repetition of a scan Please contemplate the repeating of a scan ONLY if suspect or significant artifact are evident in a patient's images, or if a patient's position appreciably changed during the exam.
2-6
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2.7 Protection from ionizing radiation WARNING: NewTom 5G is a radiological device and therefore it exposes operators and patients to the risks consequent to the exposure to ionizing radiation. It must be used according to safety rules that are contemplated by the local laws regarding this matter. WARNING: NewTom 5G mustn't be used for routine examinations or screening. For this purpose consider other diagnostic tools. Imaging examinations performed on each patient must be justified, so that it can be shown that the benefits outweigh the risks of use. Always carefully follow the applicable regulations about radio-protection and the directions from a Certified Radiation Protection Expert. ✔
Operator An operator must oversee the examination process from his/her control position according to the laws in force; NO ONE SHOULD BE BY THE PATIENT DURING THE EXAMINATION PROCESS. If a patient panics and an operator's intervention is needed during the examination process, the operator must be equipped with proper protection clothing and devices, according to the laws. WARNING: Never stand close to the device during x-ray emission.
✔
Patient It is the operator's responsibility to protect the patients from needless exposures to x-ray. WARNING: Consider the possibility to use a leaded cloth to protect the patient from the scattered radiation. WARNING: In the prescription of radiographs for pregnant women, consider carefully the possible consequences of the fetus irradiation. When possible the irradiation of a fetus should be avoided. WARNING: Consider the possibility to use a leaded apron with thyroid collar to protect the patient from the scattered radiation.
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2 About safety
WARNING: Potential detrimental interaction off the CT X radiation with active implantable medical devices and body worn active medical devices. Contact the manufacturer of such devices for more infomations.
✔
Devices displaying the emission The x-ray emission status is identified by:
1. A signal on the workstation screen such as the one reported below. It appears on video just after the START command has been selected via keyboard or mouse (see Chapter 6 “Scanning“). It is displayed all along the scan process.
2. Light indicators (LEDs) inside the control panels. They can be found on the sides of the scanner gantry. They light on just after the START command has been sent via keyboard or mouse (see Chapter 6 “Scanning“). They stay on all along the scan process or emission.
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2 About safety
WARNING: If the x-ray emission signals are on when the specific command has not been selected or if they are off after a START emission command or if the x-ray emission does not stop after the expected time, IMMEDIATELY TURN THE DEVICE OFF and contact technical assistance.
2.8 Protection from laser exposure The device is equipped with a double laser in order to aid the operator during the patient positioning. The vertical line identifies the central sagittal plane of the reconstructed volume. The horizontal line identifies:
– –
in case of Large field scan, the occlusal plane. In case of other scan modalities, the central axial plane of the reconstructed volume.
WARNING: Do not stare into the laser beams, do not view directly with optical instruments, and avoid direct exposure to the beam. The beams can cause permanent eye damage.
WARNING: Keep your eyes at least 40 cm from the laser when the beam is on. If necessary, use appropriate protective glasses.
WARNING: The use of controls, adjustments, or the performance of procedures other than those specified herein may result in hazardous radiation exposure.
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2 About safety
2.9 Devices connected to the NewTom 5G console Workstations, displays, printers, keyboards and other devices which may be connected to the NewTom 5G console MUST comply with ISO and/or IEC and/or EN standards and/or local laws in force. QR srl is available for further information. QR s.r.l. is available for additional details about this matter. NOTE: The manufacturer is not accountable for malfunctioning of parts that were not approved by the manufacturer, or not technical staff qualified and certified by the itself.
faults and/or supplied or installed by manufacturer
Food and beverage may not be placed or eaten/drunk close to the device and the workstation.
2.10 Maintenance time lag Please be sure that the maintenance controls that are described in Par. 3.4 “Device maintenance“ are performed.
2-10
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3 Safety and maintenance of the device
3
Safety and maintenance of the device
This chapter includes information about environmental safety and care for the device. General information and procedures regarding the device maintenance are also provided. The user is responsible for a proper use of the system, according to the instructions and procedures which are described inside this manual. Particularly an user must comply with the following points:
✔ The device may be used only by authorized and properly trained (about the system and the protection from radiation exposure) personnel. He/she may also know the regulations regarding the use of radiological devices. ✔
The device may never be used in case of any evident electrical mechanical or radiological malfunctioning. Especially a device can not be used whenever the x-ray emission displays and/or the emergency button are not working properly.
3.1 Installation requirements The system must be installed in a medical environment, according to a Qualified Expert recommendations. A device may not be exposed to acids, corrosive substances, saltiness and wet. Operating temperature: Operating humidity condition:
from +10° to +35° (Celsius) min 10%, max 85% (not condensing)
Installation site minimum dimensions:
3.30m x 2.50 x 2 m (130'' x 98.5'' x 80'')
The device must be installed on a flat horizontal floor. The power supply connection must be implemented according to the laws in force and to the instructions from the “Service Manual”. Don’t use temporary connections such as adapter and extension cords to connect the computer and peripherals to the mains. The equipment should be permanently connected to the mains according to the instructions stated in the “Service Manual”. The medical environment for the installation has to be designed by an expert in protection from ionizing radiation exposure according to the laws in force. Local laws shall also rule the design of the signposting. WARNING: Never move a device after it has been installed. Moving a device may damage people, the device itself or the environment. Connect only approved peripherals, computer and cables to the equipment as specified by the manufacturer.
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3 Safety and maintenance of the device
WARNING: Be sure that the device is connected to a power supply with protective earth (ground)
NOTE: The workstation must be located outside the patient's area. Cables connected to the workstation can ONLY be used to connect the workstation itself. Such cable and their connections can ONLY be handled by authorized and qualified personnel.
3.2 Guidelines for safety The device is not protected against liquid or gas infiltration. Liquid intrusion may damage the electrical parts and put the patient, the user and the environment in danger. Safety systems of the device do not decrease safety measures against the risk of fire in the place in which the device has been installed.
3-2
✔
Electrostatic discharges Electrostatic discharge may damage electrical parts in the device. Consequently the floor in the installation room should be made of antistatic materials.
✔
Extinguisher CO2 extinguishers should be installed in an easily accessible area.
✔
X-Ray lamp It is possible for the user to install a x-ray lamp in order to signal the ready and emission states of the x-ray source.
✔
Door switches The system contemplates the possibility for the installation of an external switch that can stop the emission (typically installed on the entrance of the device room).
✔
Electromagnetic compatibility For information regarding the electromagnetic compatibility please refer to - “APPENDIX A- Technical references“.
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3.3 Device modifications Possible modifications or updates for the system must comply with the laws in force. WARNING: It is forbidden to open or manumit the device with any tool. Whatever change (hardware or software) that was not previously authorized is forbidden and can inhibit a proper working in the device. It may also damage the patient, the user, the device and the environment.
3.3.1 Responsibility limits The manufacturer is not in charge for safety, reliability and performance features in the following cases: ✔
Installation, maintenance, changes, repairs and/or updates were not performed by personnel that was not directly authorized by the manufacturer or distributor.
✔
Replace parts were not approved by the manufacturer or distributor.
✔
Environmental conditions were not conform according to the requirements of the laws in force and to the suggestions of a qualified expert.
✔
The device is used in a way that is not corresponding to what is described inside this manual.
3.4 Device maintenance WARNING: Always turn the power off the device before any maintenance act.
WARNING: The device has no repairable part inside. Never remove the device covers.
WARNING: The only part that can be repaired by the user is the input fuse. It is placed in the input panel, on the control box side. New fuses must comply with the manufacturer specification.
WARNING: In order to guarantee protection against the risk of fire, replace only with fuses of the same type and range.
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3 Safety and maintenance of the device
✔ Regular maintenance Regular maintenance is required to guarantee a proper working of the device and safety for the patient, the user and other people. The device maintenance and repair must be performed only by personnel that was directly authorized by the manufacturer or the distributor. Every part of the system can only be tested and if needed substituted by qualified personnel. WARNING: If the NewTom 5G unit has not been used to scan patients for longer than three months, please perform a beam forming procedure (refer to “Acquisition Operations with NewTom VGi5G” document, annex to the “NNT User Manual” document)
3-4
✔
Dangerous cleaning substances Some cleaning substances should be avoided to prevent damage to people and to the device (See Par. 3.5 - “Cleaning and disinfection”).
✔
Preventive maintenance Please periodically check the workstation-scanner, workstation-control box and control box power supply cables. Also verify the connections between the workstation parts (display, keyboard, mouse, printer) according to the manufacturer instructions.
✔
Parts and accessories storage Other parts or accessories must be carefully stored according to their technical specifications.
✔
Malfunctioning If the system is not working as described inside this manual, please immediately contact the technical service.
✔
Maintenance agreement The device should be periodically checked: please contact the manufacturer or distributor to discuss for a maintenance contract
✔
System testing check list The following check list specifies the suggested time spaces for the system controls. For further information please contact Your local distributor.
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3 Safety and maintenance of the device Responsable
Part
Activity
Frequency
Routine testing User
Local Support Service
Global system
QA Phantom check
Weekly
Error log
Check
12 months
Every external part
Damage check
12 months
Emergency buttons
Emergency test
12 months
Electrical functioning
Check
12 months
Mechanical functioning
Check
12 months
Other test depending of local regulations Radioprotection Global system expert or other qualified person depending on local regulations
Radiological test Radiological test conforming to the local conforming to the regulation concerning X-ray local standard medical electrical equipment. This tests in not in charge by user or local support service but may be established by local regulations.
3.5 Cleaning and disinfection WARNING: Power OFF the device before any cleaning.
Some cleaning or disinfecting products may damage Your health. Such products concentration in the air should never exceed the local laws' limits. In this aim always follow the manufacturer instructions and be sure that the room is well airy.
3.5.1 Chemical agents to avoid ✔ Do not use spray or solvent which may enter the device, causing damage electrical parts or forming inflammable mixtures. This could put in danger the patient, the user and the environment.
✔ Do not use abrasive liquids such as acetone, gas oil or alcohol (exception: alcohol can be used for the cleaning of the workstation display). These substances can deteriorate surfaces and materials that are responsible for the device proper working.
✔ Do not use substances that may release ammonia due to dissociation or decomposition. Ammonia can corrode.
✔ Do not use cleaning products containing silicone: it tends to accumulate and possibly damage electrical contacts.
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3 Safety and maintenance of the device
3.5.2 Cleaning Scanner The device must be cleaned with a wet cloth and a soft solution. The cloth should be wet before applying it on the scanner surface. WARNING: Do not apply cleaning solutions directly on the device surface.
Workstation and peripherals Follow the manufacturer's instructions for cleaning the workstation and its peripheral units. If these are missing, please refer to the previous paragraph. To clean the display use a wet cloth with alcohol or a solution made up of 1/3 to 2/3 distilled water and alcohol. NOTE: For further information about safety and maintenance of the device please contact your local distributor.
3.5.3 Disinfection Despite the device do not require any disinfection, it is suggested to use standard disinfection product for the cleansing of the head support. It 's also recommended to cover the patient support with cloth or disposable materials.
3.5.4 Sterilization No sterilization is required for the normal use of the device.
3.6 Transport and storage During transport and storage the following conditions must be observed: Transport and storage temperature: Transport and storage humidity:
from -20° to +70° (Celsius) min 10%, max 85% (non condensing)
Do not expose to acids, saltiness, rain.
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3.7 Device disposal 3.7.1 Information for the device owner This symbol, on a device label, shows that the product can not be disposed along with other urban garbage. The separate collection of this equipment at the time of disposal is managed by the dealer. When disposing the equipment the user should contact the dealer and follow the suggested procedure to allow the separate collection and recycling of this equipment at the time of disposal. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. In case of unauthorized disposal of the device there are sanctions that vary according to the local and/or regional regulations. For workstations and every other peripheral disposal it is necessary to refer to the attached instructions provided by their manufacturers.
3.7.2 Information for the Disposing/Recycle centers Divide the x-ray source, the mechanical and electrical parts, plastic covers and workstation with its peripherals. X-ray sources contain oil that must be extracted for its proper disposal. Plastic parts must be disposed through approved procedures. For other parts that have no specific instructions by its manufacturer, please refer to the local laws and guidelines about health, safety and environment protection.
3.8 Biocompatibility Cover the patient support with cloth composed by biocompatible materials, according to standard ISO 10993.
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Getting started
This chapter provides a brief introduction for the NewTom 5G system, its power on and off routines and control devices.
4.1 Introduction to the system 4.1.1 Intended use The device NewTom 5G is a cone beam computed tomography x-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area.
4.1.2 Indications for use The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. WARNING: NewTom 5G is able to produce panoramic reconstructions from CBCT acquisitions. This may reduce dose in the case where both CBCT and panoramic images are needed. However, if the system is used to simulate a panoramic image when a CBCT is not necessary, this can lead to excess radiation dose to the patient. WARNING: Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he practices to user or order the use of x-ray imaging systems 21CFR801.109(b)
WARNING: Cone beam imaging should not be used for 'routine' 'screening') examinations. Other diagnostic tools must considered. The imaging examinations must be justified each patient to demonstrate that the benefits outweigh risks.
(or be for the
WARNING: Where it is likely that evaluation of soft tissues will be required as part of patient's radiological assessment, the appropriate imaging should follow the Diagnostic Imaging Referral Guidelines of the Canadian Association of Radiologists, rather than using cone beam technology
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WARNING: In prescribing radiographic examinations of pregnant or possibly pregnant women, full consideration should be taken of the consequences of fetal irradiation. Irradiation of a fetus should be avoided whenever possible. WARNING: This device is particularly designed for use on patients more than approximately 11 kg (24 lb) in weight and 87 cm (34.25 in) in height; these height and weight measurements approximately correspond to that of an average 3 year old. Studies have shown that pediatric patients may be more radiosensitive than adults (i.e., the cancer risk per unit dose of ionizing radiation is higher), and so unnecessary radiation exposure is of particular concern for pediatric patients.
4.1.3 Improper Use The NewTom 5G device has not been designed for the following uses and/or applications (reasonably foreseeable improper use):
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use with patients that cannot stand still during the entire scanning cycle (30 seconds max.);
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use in anatomic regions that are not within the scope of the device intended use (e.g., chest and abdomen);
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use for studying cerebral soft tissues;
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use by staff that have not received training on the device;
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use by staff that do not meet the requirements specified in the user profile;
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use in the operating theatre;
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use with removable metal objects (eye glasses, jewels, rings, necklaces) in the scanning field;
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use in environmental conditions other than the indicated ones.
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4.1.4 Device Operation A patient is made to lay down on the patient table and centered by means of 2 laser modules and "scout view" images. The scanning system performs a completely rotation around the patient. Radiological images are acquired, that are then automatically processed by the system. The result is the slices set that forms the reconstructed volume. At the end of this process the axial slices set composes the Volumetric Data. Through these data it is possible to display coronal and sagittal views of the reconstructed volume in real time. After defining a Region Of Interest (ROI), from the volumetric data the user can start the creation of a study. The ROI can be inclined from the volumetric data both to obtain perpendicular images and to correct positioning errors. Working on the study data it is possible to create panoramic, transaxial and 3D images. You can also work on these kinds of images measuring distances, angles, putting comment etc. Finally new images can be saved inside the study. The study images can be used to compile a report, that can be then printed and/or saved on a physical support. To study in deep these themes please refer to the ”NNT User Manual” document
4.2 Working principle According to the cone-beam technology, the source detector system performs a single rotation around the patient's head, simultaneously acquiring every necessary data for the volumetric reconstruction. Data acquired each scan step are the digital images corresponding to the radiographic projection. The raw data set so collected is used in the volumetric tomographic reconstruction process. The advantages compared to a traditional technique are: ✔
Direct reconstruction of any set of the scanned object points without passing through axial reconstruction and data re-formatting.
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Total scan time related to the acquisition electronics, rather than to the x-ray tube power and the mechanics, usually shorter;
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Under same conditions of total scan time, less requirements in regards to the source/tube assembly power and scan mechanics, with constructive and maintenance advantages.
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4.3 Overall view The system is composed by three main parts: scanner unit, patient table accessory (patient table version, cod. 96600722 or patient table with stretcher version, cod. 96600822) and main workstation installed out of the patient area. It is also possible to add more workstations for data processing and storage. For additional informational about this matter, please refer to the "NNT User Manual" document
Figure 2: NewTom 5G complete system
NOTE: The system may not be expanded with parts or accessories other than the ones described inside this manual
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4.3.1 Control panels The scanner unit is the main part of the system. Two control panels are placed on each side of the scanner gantry. These two panel includes the indicators for the device “power ON” status and for the emission status. The control panels also include the laser button that turn ON the laser used during the patient's positioning
Figure 3: Control panels
Next is a brief description of each button and sign: Emergency button: to be used only during danger situations. To restore the default condition after pressing the button, rotate it in the direction indicated by the arrows.
Power ON indicator: A green LED turns on after the device has been switched ON by pushing the main switch located on the input panel.
X-Ray emission indicator: 3 LEDs turn on simultaneously during the x-ray emission.
Laser Button(L): Turns the positioning laser beam on/off. The laser will light up for about 60 seconds.
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4.3.2 Patient table console
Figure 4: Patient table console
UP/DOWN buttons to be used after the patient is positioned inside the gantry, to adjust the vertical position of the table (z axis).
LEFT/RIGHT-FORWARD/BACK buttons to be used after the patient is positioned inside the gantry, to adjust the position along the x and y axis of the table.
P1 button to be used after the patient is sitting in the table to move him/her inside the gantry.
P2 button to be used after the device has been turned ON to move the table to the default position. Use the P2 button also at the end of the scan to move the patient out of the gantry.
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LASER button Turns the positioning laser beam on/off. The laser will light up for about 60 seconds (only available if the connection between patient table and NNT software is active). READY – XRAY EMISSION – FAULT indicators A green LED turns on once the connection between patient table and NNT software is active. A yellow LED turns on during x-ray emission. A red LED turns on in case of patient table fault condition.
For more details about the use of patient table and complete available buttons and functions, please refer to the “Patient Table User Procedures” document.
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4.3.3 Patient table with stretcher console
Figura 5: Patient table with stretcher console
Button UP/DOWN
FORWARD/BACK LEFT/RIGHT
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Function Raise and lower the table
Warnings These movements are not allowed in case of "facilitated uphill position". The minimum / maximum excursions of the movements are limited to defaults values by active collision controls.
Not available
Not available. Physically, the stretcher can be moved only in manual mode
Transversal movement
Transversal table movement is not allowed in case of "facilitated uphill position". The minimum / maximum excursions of the movements are limited to defaults values by active collision controls. Operation allowed when the display show a window with P1 symbol (ie if the stretcher is completely out of the gantry with active limit switch). Operation allowed when the display show a window with P2 symbol (ie if the stretcher is completely out of the gantry with active limit switch).
P1
Start sequence "Exam Preparation Position"
P2
Start sequence “Facilitated Uphill Position”
+/-
+ / - buttons
The function depends on the current page displayed on the screen
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Laser ON / OFF buttons
The button is active only if the communication 5G / PC is active
F1 / MODE / F2
Navigation menu buttons F1 / MODE / F2
The function depends by the icon displayed on the screen in correspondence of the relevant key A green LED is on when the connection between 5G and PC is active A yellow LED is on when an x-ray emission is active A red LED is on when when an anomaly occurs. The operator attention is required
READY X-RAY EMITTION FAULT
5G/PC connection Led X-ray emission Led Fault Led
For more details about the use of patient table and complete available buttons and functions, please refer to the “Patient Table User Procedures” document.
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4.3.4 Input panel and main switch On the left side of the device is located the input panel, which includes the main switch to turn the system ON/OFF and the fuse holder. The input panel also includes the connectors for the CAN Bus and the Ethernet cables (to be connected to the workstation console) and the cable glands for the power supply cable and for the cable of the remote emergency button.
CANBUS CONNECTOR
ETHERNET CONNECTOR
MAIN SWITCH CONNECTOR
FUSE HOLDER
Figure 6: Input Panel and connectors
4.4 Standard accessories The device is supplied with a few standard accessories:
QA phantom: used for the execution of the Quality Assurance procedure.
Calibration support: Plate to be used for the positioning of the QA phantom on the patient table.
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Calibration support: Plate to be used for the positioning of the denture on the patient table.
4.4.1 Cables The device also includes linking cables between workstation console and scanner unit. They are:
✔ Ethernet cable (4 pairs/26 AWG-FTP-5E) ✔ CAN bus cable (2 pairs/24 AWG shielded) The manufacturer also provides the power supply cable with an end connected to the scanner unit, it is in charge of the user to connect it to the mains during installation.
ETHERNET CABLE CANBUS CABLE
WARNING: Accessories, transducer and cables different from the ones here specified may change the electromagnetic compatibility characteristics of the device.
4.4.2 Optional accessories At the present time no optional accessories are available for a NewTom 5G system.
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4.5 System start-up To properly switching the device on: 1. Turn on the scanner unit by pushing the main switch located on the input panel (left side of the device). 2. Turn on the workstation. Wait for the Operating System to be load. 3. Log in the Operating System with assigned User name and Password . 4. Start NNT software. NOTE: Always turn the scanner unit on first. If You try to use the NNT software before the appliance has done its initialization successfully, an error will occur (see Chap. 8 “Troubleshooting“)
4.6 System shut down Next is the procedure for a proper turning off of the device: 1. Close the NNT software. 2. Shutdown the workstation console. 3. Turn off the scanner unit by pushing the main switch located on the input panel(left side of the device). WARNING: Turn off the device when it has not been used for longer than 3 hours. WARNING: Always turn the device off at the end of the working time.
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Preliminary procedures
This chapter describes the procedures to perform compulsorily before starting scanning patients. There are three of these procedures:
✔ X-Ray source conditioning; ✔ Daily check; ✔ Blank acquisition; This chapter also describes the following functionality: ✔
Beam limiter test
X-Ray source conditioning and Blank acquisition must be performed every two weeks (14 days), while Daily check is mandatory every day, before patients acquisitions. If these procedures are not performed the software will disable the scan functions. Operating modes are described in detail in the same named chapter from the "NNT User Manual" document.
5.1 X-Ray Source Conditioning The conditioning procedure is necessary in order to prepare the x-ray source for its routine working. It is compulsorily and automatically required by the NNT software every two weeks.
Figure 7: Initial NNT screenshot with request of X-Ray Source Conditioning
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WARNING Before launching the procedure, please verify that the scan area is completely free from objects.
Figure 8: X-Ray Source conditioning process running
At the end of conditioning process, the software will automatically run the Daily Check and Blank acquisition procedures.
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5.2 Daily Check By running the Daily Check procedure the system verifies that each part of itself properly works.
Figure 9: Initial NNT screenshot with request of Daily check
WARNING: Before launching the procedure, please verify that the scan area is completely free from objects.
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Figure 10: Daily check running
5.3 Blank acquisition During Blank acquisition a background image is acquired in order to verify and calibrate the detector performances. This procedure is compulsorily and automatically required by the NNT software every two weeks.
The resulting blank acquisition image should look like shown in the figure. Please carefully verify that no artifacts or objects appear. WARNING: Before launching the procedure, please verify that the scan area is completely free from objects.
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5.3.1 Invalidating the Blank acquisition In the event that Blank acquisition has been performed with an object inside the scanning area, you will have to invalidate the blank acquisition and repeat the operation. To invalidate the blank acquisition select Scan Invalidate Blank from the main toolbar. At the next detector field selection the NNT software will ask a new blank acquisition.
WARNING: If the test has been performed correctly but has not been completed successfully, please contact our Technical Support.
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5.4 Beam limiter test This functionality has the purpose of allowing the user to check proper collimation. The collimator's positions are pre-set by the manufacturer and may not be changed by the user. 1. From the main toolbar select Tools Scanner Test. 2. From the window bar select Tools Beam Limiter Test. Select the desired FOV. 3. Set the radiological parameters depending on the selected FOV (Standard: SFS, 1 mA, 10 msec, KV = 110; HiRes standard: SFS, 6 mA, 10 msec, KV = 110) 4. Perform an acquisition. 5. Verify the acquired image is correctly collimated (the green rectangle should be entirely included in the gray acquired area. The edges of the rectangle must be included between the two couples of red lines).
Figure 11: Beam limiter test
WARNING: If the grey image acquired is not correctly collimated within the red lines, please contact our Technical Support.
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Scanning
This chapter describes the procedures to follow for a proper patient's or denture positioning and examination. The exact procedure to perform a scan on a patient or on a denture can be found in the corresponding chapter inside the “Acquisition Operations with NewTom VGi-5G” document, annex to the “NNT User Manual” document. It is also suggested to refer to Chapter 2 - “About safety“ and Chapter 3 - “Safety and maintenance of the device“ It is possible to perform the scans in the following modalities: – – – – – – – – –
[18x16] (volume diameter 18cm, height 16cm); [15x22e] (eFOV scan)3 [15x12]; [12x8]; [8x8]; [15x5] HiRes (High Resolution); [12x8] HiRes; [8x8] HiRes; [6x6] HiRes. WARNING: Use the smallest field of view required, based on the clinical requirements. In general, for small size and pediatric patients it is recommended to use the smallest FOVs available (i.e., 6x6, 8x8, 12x8, 15x5).
It is possible to perform the scans with 3 different options for each reported modalities 4:
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Eco Scan:
< image quality, < exposure time for all modalities < scan time only for HiRes modalities
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Regular Scan:
default option for image quality, scan time and exposure time
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Enhanced Scan:
> image quality, > scan time and exposure time
WARNING: For children, we recommend using the lowest dose and fastest scanning mode available: ECO SCAN.
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FOV available only with the patient table with stretcher and software option enabled. “Enhanced Scan” option not available in case of eFOV scan
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The choice of the modality can be performed selecting the corresponding FOV button from the "Scan Manager" panel located on the bottom right corner of the NNT main window.
6.1 Patient scan 6.1.1 Patient preparation An important step in a scan routine is well preparing the patient. This can contribute to a proper scanning and to high quality images. The aim of such preparing is making the patient relaxed and in a good position before and during the scan. Here are some suggestions that can help in this concern.
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Room setting Be sure that the scanner unit is clean and ready to scan ("Daily Check" and "Blank Acquisition" already performed).
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Preparing the patient Ask the patient to remove if present any jewelry (earrings, necklaces), glasses and removable metallic prothesis.
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Accommodating the patient After accommodating the patient in the patient table, move it in the scan area and adjust the table so as to frame the interested area and the neck/bust of the patient assumes a correct position.
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Explanation of the examination Please explain in short the scan routine to the patient, including the data collection process, the positioning and scanning.
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Particular patients A special care has to be taken in case of children, elderly people, claustrophobic people, physically or mentally disabled.
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Proper breathing Ask the patient to breathe slowly during the scanning (a slow and continuous breath helps from swallowing). NewTom 5G – User Manual
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Relaxation Ask the patient to keep the mouth closed without grinding the teeth together.
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Avoiding delays Good examination times can be obtained also by carrying out all the preliminary procedures before starting the scan itself.
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Voice instructions Introduce the patient to possible voice instructions that the operator may give during the scan.
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6.1.2 Positioning the patient and starting a new scan Hereafter is a description of how to position and center a patient inside the scan area. Perform these action just when the software signals them. For more details about use of the patient table, please refer to the “Patient Table User Procedures” document. The guidelines for patient positioning during examination of the different anatomic regions are outlined in the attached document “General guidelines for the use of the NewTom 5G device in the dental and medical field”. WARNING: The scan area (the place in which a patient is positioned during the scan) must be free from any objects, except from the head support. They may damage the patient or invalidate the scan results.
WARNING: Pay attention while moving the patient's table in order to avoid possible collision with object and/or person.
NOTE: Pay attention to don't load excessively the parts of the patient table. The allowed maximum loads are: Patient Table: Head-Rest: 15 Kg / 33 lbs Back-Rest: 52.5 Kg / 115 lbs Seat: 62.5 Kg / 138 lbs Feet-Rest: 30 Kg / 66 lbs Patient Table with stretcher: 1) Maximum load (for zone)
Stretcher out of the gantry Zone A: 35 Kg / 77 lbs Zone B: 175 Kg / 385 lbs Zone C: 175 Kg / 385 lbs
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3) Distribution of maximum rated load 175kg (160kg + 15Kg accessories)
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6.1.2.1 Patient positioning with patient table 1) After the device has been turned ON, the patient's table position should be reset (default position for patient accommodation). This task can be accomplished by pressing the P2 button on the table console.
PATIENT TABLE DEFAULT POSITION
2) Help the patient to sit down on the table with the head resting on the head support.
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3) Move the table inside the scan area by pressing the P1 button. Assure the patient will keep a correct posture and remember him/her to do not swallow, gnash the teeth and move during the positioning process.
PATIENT TABLE SCAN POSITION
4) Finely adjust the patient position by using the table console buttons.(UP/DOWN – LEFT/RIGHT FORWARD/BACK). In order to help the operator during the positioning of the patient, the laser can be turned on by pressing the LASER button on the scanner control panels or on the table console (required the NNT software to be open).
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