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
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Description
Defibrillation-proof type B applied part
Ionizing radiations
Directive 2012/19/EU
Disposal of WEEE (Waste from Electrical and Electronic Equipment)
Directive 93/42/CEE
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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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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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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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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2.9 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 faults and/or malfunctioning of parts that were not supplied or approved by the manufacturer, or not installed by technical staff qualified and certified by the manufacturer itself.
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.
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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.
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✔
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“.
NewTom 5G – User Manual