manuale uso 3.0 eng
DESCRIPTION
manualTRANSCRIPT
SIRIO
User Manual
Revision 3.0
Approval
Written by Data:Brunetti Gioacchino, Specialized researcherSchiraldi Vito, Specialized researcher
Revised by: Data:Larizza Pietro, Research and Development Resp.
Approved by: Data:Marino Domenico, Quality Resp.
Approved by: Data:Vinci Angelo Michele, Legal Representative
SIRIOUser Manual
Revision 3.0
2
Produced by:
MASMEC S.p.A.Via Dei Gigli, 21Modugno 70026 - BARI(+39) 080 5856111
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TOC
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INFORMATION REGARDING THE OPERATOR
This manual provides detailed information regarding the use of the SIRIUS medical system. Read this section carefully before continuing with the rest of the manual.
Warning
SIRIO is a medical device and should be used only by qualified, trained medical personnel.
Before using SIRIO, read this guide paying special attention to all the warnings emphasising every single paragraph.
When carrying out a minimum invasion surgery intervention using the SIRIUS system, the same minimum invasion standards, principles, procedures and uses universally recognized are implemented. The device is designed exclusively as a tool intended to aid the radiologist in surgical procedure operations.
All numerical values presented in this manual are examples only.
The SIRIO system is exclusively designed as a calculation instrument, used as an auxiliary to surgical activity; therefore, any responsibility connected to and/or arising from its use is attributed to the User.
The system must be installed by a qualified service engineer. Do not try to disassemble or open the system. Only qualified service staff may perform system interventions.
Do not use the system in the presence of flammable materials such as solvents, cleaning agents and endogenous gases. Flammable materials may catch fire, causing personal injuries or death.
Do not transport or store the system in ambient temperatures not included in recommended temperature ranges, since this could lead to system de-calibration. The use of data provided outside of calibration parameters could lead to inaccurate conclusions and cause personal injuries.
Radio frequency communication equipment, including mobile devices and mobile phones, could impair the functionality of the system and cause personal injuries.
Do not use cables and accessories different from those provided in this manual. The use of other cables or accessories can increase emissions and/or immunity reduction and cause personal injuries.
All maintenance operations must be performed by qualified personnel. Maintenance carried out by non-specialized personnel may involve electric shock risks.
Do not submerge any system parts or allow fluids to penetrate the system. If liquids penetrate within any system parts, they could cause damage to the equipment and constitute a risk of personal damage.
Do not use the system without having inspected the cleanliness and integrity before and during a procedure. The use of data provided by a damaged system could lead to inaccurate conclusions and cause personal injuries.
Do not use the intervention specialized kit without having first inspected the integrity and cleanliness before and during a procedure. Verify sphere integrity and the cleanliness. The use of data provided by damaged spheres or cleanlinesses lack can lead to inaccurate conclusions, putting patient safety at risk.
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Accessories connected to input/output of the interfaces must comply with IEC standards (for example, IEC 60950 for equipment data processing and IEC 60601-1 for medical equipment). In addition all configurations must be in compliance with a IEC 60601-1-1 valid version. Anyone who connects to the system to additional equipment in fact configures a medical system, consequently it is necessary that such a system is in accordance with the requirements a valid version of IEC 60601-1-1 standard system. If in doubt, please consult our technical service department.
Instructions - fields of application
SIRIO is a medical device designed to support the procedure implementation of minimum invasive intervention radiology in the thorax region, involving a needle probe insertion. In particular, the system is considered an auxiliary tool for biopsy sampling and thermal rehabilitation of lung nodules. Use of the device is indicated in all cases where the clinical conditions exists without a doubt and are detected by the medical staff. The device is used to conduct a radiology procedure in the chest area, through the insertion of a needle probe.
Contraindicartions
Use of the device is not indicated in all cases where the clinical conditions do not exist, this being determined by the medical staff. The device is used to conduct a radiology procedure in the chest area, through the insertion of a needle probe.
Informational material convention
Bellow, a table containing symbols used in this manual is presented.These symbols warn the user of a safety condition presence requiring his attention. It's necessary to be able to recognize and understand the meaning of the following hazards in order to ensure operator and system devices safety.
Colour Symbol Warning Danger level
Red DANGER
Indicates a situation of imminent danger that, if not avoided, will cause death or serious injury.
Orange WARNING
Indicates a potential dangerous situation that, if not avoided, may cause death or serious injury.
Yellow ATTENTION
Indicates a potential dangerous situation that, if not avoided, may cause moderate lesions.
None ATTENTION
Used without the safety alert symbol, indicates a potentially hazardous situation which, if not avoided, could result in property damage.
Red, orange or yellow ELECTRICAL
Indicates an imminent electrical hazard that, if not avoided, may result in personal injury, fire and/or death.
White ATTENTION
System symbols
Symbol Meaning
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System start-up
Hardware warning
Potential equalization
Power isolation (grounding)
Position sensor start-up LED
Indicates position sensor status
Indicates a position sensor error
Laser warning
Direct current
Ethernet connection
USB interface
Connection portIndicates that the unit must be sent to special agencies for the differentiate harvesting in accordance with local regulations once its operating lifetime has ended
Applicable European directive system conformity symbol.
Technical assistance
In case of operating system problems, it is recommended to consult the troubleshooting table in appendix 4.2.The above mentioned table describes common problems and their solutions.
If you continue to encounter problems after following the recommended actions, contact MASMEC SpA for specialised assistance:
E-mail: [email protected]
Telephone number: (+39) 080 5856 261
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Fax: (+39) 080 5856 300
Incident notification
Incident means a malfunction or deterioration in device characteristics and/or performance, as well as any inadequacy in labelling or in utilisation instructions which, directly or indirectly, may led or have led to death or serious impairment of patient's health, an operator or third person.
In the event of an accident, the customer must immediately report the occurrence to MASMEC SpA who will recall the system and carry out a detailed analysis:
E-mail: [email protected]
Telephone number: (+39) 080 5856 111
Fax: (+39) 080 5856 300
A thorough investigation will be carried out upon receipt of the device involved in the incident, a detailed results report will be produced and subsequently, system revision.
The revision will conclude if the accident is similar or not to a previous known accident. Any event associated with all three criteria described below shall be considered an accident and will be reported to competent national authorities. The criteria are:
a. An event has occurred.b. The device is suspected of having contributed to an accident (characteristics or performance
malfunction or deterioration)c. The event has led, or could have led to one of the following results:
death of a patient, or third person A patient's (or third person) health serious deterioration.
If necessary, recall of all product and/or component lots deemed as possible accident cause will be carried out. The products/components will be placed under quarantine until a final result is defined.
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1 SECTION 1: SYSTEM OVERVIEW
1.1 INTRODUCTION
SIRIO is a biomedical computerized system designed to provide the medical staff, operating within the thoracic pathology percutaneous intervention radiology field, with tools able to aid recent techniques of minimally invasive intervention carried out under CT guidance, allowing probe insertion trajectory detection (for biopsy and thermal ablation) in order to reach even small size neo-formations (less than 1cm), in areas not examinable with other techniques.
Traditional procedures for percutaneous intervention carried out under CT guide provide an iterative procedure in search of surgical needle entry point and subsequent incision tracking: each intervention needle advancement or rotation is followed by a CT check scan, followed path check, in order to be able to have wide margins of correction.
The operational methodology introduced by SIRIO revolutionizes the traditional technique mentioned above: after the device has performed an area scan of the anatomic region on which an intervention is going to be performed upon and after the device has provided a three-dimensional image, SIRIO, thanks to its real-time navigation, allows a quick detection of surgical needle insertion direction and an extremely precise positioning of the progression within the anatomic region being intervened upon.
This procedure avoids unnecessary radiation, leaving, at the same time, the interventionist radiologist doctor with a wide freedom of choice to perform at any time, at his discretion and in accordance with his reasons, additional undertaken trajectory CT control scans as he deems appropriate.
The system interfaces with the server data transmission of a CT scan in order to capture the scans of a patient's particular anatomic region who is to undergo interventional procedure, these constituting the basics of system operation. From the scans provided by the CT, SIRIO is able to reconstruct a three-dimensional model of the area; same area is closely related, regarding spacial positioning, with the real anatomical area of a patient through a completely automatic registration procedure, therefore, completely transparent to the operator, which uses a reference tool to the patient. Movement and position consistency of an intervention probe in relation to a probe model created in a virtual environment is guaranteed by registration procedures of the patient and the probe, described in detail in paragraphs 3.7 and 3.8.1. The system also provides support for pre-intervention phase allowing optimal trajectory identification, through the use of advanced graphics tools: rendering and three-dimensional measurement.
The system is composed of a processing and display unit and a infrared optical tracking sensor, with the related field devices, used in different SIRIO operation stages: anatomic region registration (par. 3.7), plunging trajectory identification (par. 3.8.2), recording (par. 3.8.1) and tracking (par. 3.8.3) of intervention probe.
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Image 1.1: SIRIO system overview.
Infrared tracking sensor
and field devices
Tomograph
Processing and display unit
Specialised intervention kit
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1.2 SYSTEM COMPONENTS
PROCESSING AND DISPLAY UNIT
Image 1.2: Processing and display unit front and side view.
Image 1.3: Unit details.
a. Powered carriage for LCD
b. LCD touch screen for medical applications
c. Secure closing, advanced acquisition and processing unit for non visualisation compartment.
d. Compact keyboard with integrated trackball
e. Power supply connection
f. Data tracking and transmission system connection
g. System power-on interface and uninterruptible power supply monitoring
POSITIONING SENSOR1. Positioning sensor
2. USB converter
3. Power supply adaptor
ba
cbdcg
f
ed
a
1
ed
f g
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Image 1.4: Positioning sensor.
SPECIALISED INTERVENTION KIT
Image 1.5: Specialised intervention kit
I. Patient Tool
II. Needle Tool
III. Direction Tool
NEEDLE SUPPORT
Image 1.6: Intervention needle support.Sterile intervention needle support (from 14G, 17G, and 20G)
BREATHING MONITORING SENSORS
I. Breathing Sensor
II. X-Ray Sensor
II
I
III
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12
Image 1.7: Breathing monitoring sensors.
POSTURE MONITORING MARKER
Image 1.8: Adhesive posture monitoring markers
Group of 12 reflective markers
I
II
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1.2.1 PROCESSING AND DISPLAY UNIT
Powered carriage for LCD
This is an innovative carriage designed for the health care field. The carriage is ergonomic and easily manoeuvrable. Designed for health-care staff and engineered to fit immediately in the context of Information Technology, the carriage is characterized by:
A. Screen independent positioningB. hight adjustment for best
ergonomic positioningC. acquisition and processing unit
compartment security and flexibilityD. automatic locking drawerE. keyboard shelf with backward tilt F. manoeuvrability that does not
require effort
In order to ensure patient and medical staff safety, the carriage and the power supply system are certified according to EN IEC 60601-1 standard.
Carriage technical characteristics are presented below (Image 1.10):
Image 1.9: Powered carriage functional characteristics.
AB
C
DE
F
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Image 1.10: LCD powered carriage technical details.
1. The height-adjustable stand allows liquid crystal display mounting on a 75 x 75 or 100 x 100 mm support
2. Work surface: (a) carriage monitoring interface (b) self-closing keyboard drawer 3. Secure notebook space, Thin Client or CPU thickness up to 95 mm4. Front handle5. Height adjustment lock6. The "Ready On" start-up button returns the computer to full functionality mode from stand-
by mode.7. USB hub8. The keyboard shelf slides out, and tilts, allowing mouse use to the left or right with proper
care.9. Light keyboard under the front handle10. Excess cable and power supply compartment.11. Utensil holder compartment and rear handle12. Front swivel and lockable wheels13. Automatic locking drawer14. Carriage base integrated power supply system.
LCD touch screen for medical applications
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The touch screen is intended for the medical field and optimized for advanced visualization of medical images, is compliant with strict safety standards and electromagnetic compatible with medical equipment.
The monitor has an integrated LCD panel with excellent quality and an extraordinary level of brightness, contrast and colour depth, ensuring a natural video playback, quality hardly obtained with conventional monitors.
Image 1.11: LCD monitor for medical applications.
Secure closing, advanced acquisition and processing unit for non visualisation compartment.
This is an advanced medical image management unit compliant with DICOM standards, starting from diagnostic equipment acquisition, specifically a computerized tomograph, to advanced display and processing.
1.2.2 THE POSITION SENSOR
The position sensor is an optical system designed to measure the 3D marker locations applied on specialized tools. Using this information, the SIRIO system is able to determine tool position and orientation within a specific measurement volume.
The system operates as following (Image 1.12):1. The position sensor emits infra red
radiation (IR) from its IR emitters, like a flash on a camera.
2. The infra red radiation covers the surrounding area and is reflected back by the tools' passive spheres present in the intervention ambient.
3. Then, the position sensor locates the sphere's position and calculates tool transformations (position and orientation), meaning sphere position.
4. The position sensor transmits the processing data through the USB
Image 1.12: Position sensor operating principle
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conversion system to the subsequent manipulation processing unit.
The sensor is composed of following elements (Image 1.13).
IR emitters Two infra red emitting diodes (IRED) that spread IR light on the tool's reflecting balls.
Sensors Two sensors each comprising a lens and a device capable of detecting incident radiation (CCD, charge-coupled device).
LED indicators Three LED that provide the following information (Image 1.14):
- Power supply LED :Flashes green during the initial preparation stage (warm-up). Continuously glows with a green light when the system is ready for use.
- Status LED :Continuously glows with a green light when the communication connection between the position sensor and processing unit is available.
- Error LED :Continuously glows with an amber light when a critical error is detected (the sensor must be shipped back to MASMEC); a flashing amber light is present when a non critical error has been detected.
Laser outletThe positioning laser beam is emitted through this opening.
Laser activating button Press this button to activate laser positioning. The laser remains active only while the button is pressed and held.
The USB converter provides the interface between the position sensor, power adapter, and processing and display unit (Image 1.15):
- The built-in cable connects the USB converter to the position sensor, it's
Image 1.13: Positioning sensor.
Image 1.14: LED and laser outlet proprieties.
Sensor
Laser activation
LED indicators
Laser outlet
IR transmitter
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function being data transmission and sensor power supply;
- The USB cable and power adapter are inserted directly in the converter. The USB connection constitutes the signal functional connection between the position sensor and processing unit.
Characteristic measurement volume
The position sensor's characteristic measurement volume represents the area within which the system can locate a tool without any accuracy of calculation compromise.
The volume has a pyramidal spatial characteristic (Image 1.16). Bear in mind that the sensor has blind spot area covering up to 950 mm from the sensor and CT transmitters plane. Within the above mentioned area, the sensor is not able to locate the intervention tool.
Tool localization and tracking
The position sensor detects the tool by locating the IR radiation reflected by the spheres. The sensor transmitters emit an IR signal throughout the measurement volume; the spheres covered in a reflective coating, reflect the IR radiation back to the two sensors rather than spreading it throughout the surrounding space.
By measuring the positions of all the visible spheres, the position sensor is able to capture every single tool present in the measuring volume and, therefore, is able to follow and locate it and all its movements.
For the purposes of correct tool localization by the position sensor, taking into consideration tow basic parameters is considered necessary:
1. Maximum tool angleThis parameter specifies the maximum acceptable angle between a tool and each of the two radiation detecting
Image 1.15: USB converter
Image 1.16: Position sensor's characteristic measurement volume
Position sensor's built-in cable
USB connector
Power supply connector
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sensors present on the position sensor. The maximum allowed angle, considered as the angle between the parallel line to the plane containing the spheres and the plan itself, is theoretically equal to 90°. The actual tool use range is, in fact, linked to tool position inside of the measuring volume; but in any case never less than approximately 85° (Image 1.17).
2. Sphere visibilityThe position sensor is able to locate and follow the tool within the measurement volume only if all 4 spheres placed on individual instruments are simultaneously visible. Otherwise, the system will not be able to detect the intervention tool.
Image 1.17: Tool maximum angle example.
WARNING If one or more spheres are outside the characteristic measurement volume, the sensor will
not be able to locate the tool. In this case, the system sends a notification to the monitor about this possibility.
If intervention instrument inclination exceeds the maximum allowed angle, the position sensor is not able to locate the tool position. In this case, the system sends a notification to the monitor about this possibility.
Remove all radio communication devices that may be present in the operating room. These devices may alter the position sensor's performance, and by providing inaccurate measurements, may risk the patient's safety.
Do not look into the laser emitter outlet. The position sensor's laser module emits visible 1.2.3 SPECIALISED INTERVENTION KIT
The intervention kit represents all specialized tools necessary for proper interventional procedure execution with the help of the SIRIO device.
The kit is composed of three specialised tools:- Patient Tool- Needle Tool- Direction Tool
Each tool is a rigid structure designed and built in such a way that it guarantees the stability of the 4 applied spheres. Any relative movement between the spheres is to be avoided.The tools in question are passive wireless tools. They are not supplied with cables that could obstruct the operation.
Normal to the planeMaximum
angle
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The passive spheres included in the tools are coated with a reflective layer able to reflect IR incident radiation back to it's source.
The particular geometric configuration of each tool grants same tools with a 6 degrees error margin, allowing the system to detect the position and orientation in 3D.
Patient ToolThis is an instrument provided with sensors able to track the patient's postural position and breathing.
The Patient Tool possesses the essential constructive characteristics needed for the subsequent operating phases (para. 3.4):
- Marker point j,k l: this are reference markers used in the intervention needle recording phases (para. 3.8.1):
- The expression “MASMEC SIRIO RB02” is used as a reference to patient sensor implementation stage (par. 3.4):
The Needle ToolThis tool is used for intervention needle sensing.The tool is provided with an insertion section designed for intervention instrument introduction. Depending on the particular needle used for the operation, the use of suitable adapters may be necessary in order to ensure a correct instrument assembly (para. 3.2.2):
The Direction ToolThis is the tool used for insertion direction identification.The tool is provided with an insertion section (Image 1.20) designed to ensure stable and firm compatibility with the needle support star joint (para. 1.2.4).
Image 1.18: Patient Tool and its fundamental characteristics
Image 1.19: The Patient Tool and its fundamental
Marker point
Insertion section
Words of reference
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characteristics
Image 1.20: The Direction Tool and its fundamental characteristics
WARNING The tools may be re-sterilized. The use of a tool subjected to a new sterilization can affect
the functionality of the whole system in an adverse manner, putting the patient safety at risk.
Do not use a tool without having first inspected the integrity and cleanliness before and during a procedure.
Verify sphere integrity and the cleanliness. The use of data provided by damaged spheres or cleanlinesses lack can lead to inaccurate conclusions, putting patient safety at risk.
Do not handle the tools using bare hands. This may cause the skin to release residue, which may compromise sphere reflectivity.
Do not submit the tools to impact. This may affect the correct system operation. Do not drop the balls or scratch the coating because it may lower reflectivity.
1.2.4 INTERVENTION NEEDLE SUPPORT
The system is used to facilitate insertion direction research phase and provide support for the intervention needle during the entire operation phase.
While the operation is aided, the support is a not a strictly necessary accessory for operation implementation and, as such, does not provide any additional information.
Insertion section
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Trajectory research is rendered extremely easy by two plastic hemispherical arches, allowing an 180° solid angle adjustment, maintaining the entry point fix. The system is complete with a 4 cm catheter constitutes the needle access channel (Image 1.22).
The system's star shape locking coupling (Image1.23) allows a stable direction upkeep, direction set by the Direction Tool and angle maintaining during the entire phase of needle insertion, regardless of the desired depth.
The tool produced by the support provides a visible indication of the path set by the Direction Tool, at the time of the control tomographic scan of undertaken trajectory (Image 1.24).
While firmly maintaining the chosen direction of the entire insertion phase, the support also allows multiple biopsy sampling of the same lesion or even different intervention procedures.
Image 1.21: intervention needle support.
Image 1.22: Hemispherical adjustment arches and needle access catheter.
Image 1.23: Star shape locking coupling detail.
Image 1.24: Needle support tool.
Hemispherical arcs
Access catheter
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The support is available in different configurations, allowing different needle size mounting according to the chart below (Image1.26):
Description Colour Usable needles14G Support Green 14G 15G17G Support Red 17G 18G20G Support Yellow 20G 21G
Image 1.25: Multiple samples authorized by SIRIO.
Image 1.26: Needle support tool possible configurations.
WARNING Keep in mind that the needle support is 4 cm long, which must be taken into account when
calculating intervention needle length. The arc locking system is designed to maintain the position of the needles weighing less
than 20 grams and have a length shorter than 30 cm.
1.2.5 BREATHING MONITORING SYSTEM
The breathing monitoring system is composed of:
a) a distortion sensor placed on patient's belly or lower back measures the level of pulmonary extension.
b) an X-ray sensor with touch keypad creates an instant chest scan.
SIRIO relies on a static model of the thorax, reconstructed from CT scans. This model may not take into account the changes induced by patient respiration, which may produce
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deviations from the results obtained with a static model.The respiratory sensor however, constantly surveying the patient's respiratory phases is able to indicate all the moments in which the chest position corresponds to a tomographic scan.So, although it does not have a dynamic model of the chest at its disposal, it's always possible to identify the moment when a SIRIO static model corresponds to a CT scan.
Image 1.27: Patient respiration monitoring system
1.2.6 POSTURE MONITORING SYSTEM
The posture monitoring system consist of a infra-red reflective marker (Image 1.28), constantly read by the main position sensor (Image 1.13).The system's purpose is to identify changes in the patient's posture and to notify the deviation degree, expressed as a percentage, from the fixed posture recorded during the tomographic scan.This is a another control designed to overcome the limitations presented by the thorax static model reconstructed from SIRIO. Image 1.28: Posture control marker
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1.3 SYSTEM TENDENCY
1.3.1 SET UP
Component connection
The processing and display unit interacts with the infra-red position sensor for data input. The data is needed to determine operator instrument and anatomical structure position and orientation in three-dimensional space.
The two systems interact with each through two functional connections:
- power connection: the position sensor's power supply cord is plugged into a multiple socket available inside the carriage.
- signal connection: USB cable data connection through the sensor converter.
The position sensor's power connection is pre-assembled within the processing unit.The signal connection is established through the converter's integrated cable connector. If not already connected, connect the USB converter' integrated cable to the back sensor connector, aligning the red dot found on the connector, with the red dot from the connector cable (Image 1.29).
The monitor, integrated in the processing and display unit, has two connections, one is power supply, the other is signal, both rated in the unity itself (Image 1.30).
Connect the AC power supply cord by inserting the connector into the AC IN socket found on the connection panel. The next step is to connect the cable to the safety support and slide it up in order to lock the connector into the monitor (Image 1.31).Pull out the safety support by pressing the block clip to interrupt the power supply.
Image 1.29: Position sensor's connection
Image 1.30: Monitor connection panel.
Guidance references
Power cord
AC IN socket
WARNING Before connecting or disconnecting cables, first you should disconnect the system's main
power supply. Do not use cables or accessories different from those provided. The use of other cables or
accessories can result in increased emissions and/or reduction of system immunity , risking individual harm.
Do not use the position sensor without having inspected the cleanliness and integrity before and during a procedure. The use of data provided by damaged position sensor or cleanlinesses lack can lead to inaccurate conclusions, putting patient safety at risk.
Check that all cables are firmly connected and positioned so as not to be stretched, bent or trampled upon.
Inside the monitor, dangerous high voltages are present. Do not open the equipment. In case of equipment malfunctions or necessary repairs, please contact exclusively specialized personnel.
In case the monitor does not switch on, verify that the power connection is executed correctly.
In case the monitor does not display anything, verify that the signal connection is executed correctly.
Connection to the electrical network
The SIRIO device requires a single connection to the electrical networkIn particular, you must necessary connect the processing and display units' power cord to an electrical outlet.
Image 1.32: Connection to the electrical network.
WARNING Do not stretch the coiled cord further than 2.5 meters; otherwise, the risk of damaging it
emerges. The carriage must remain connected plugged into a power outlet as often as possible in
order to keep the batteries charged and the computer supplied with power.
Tomograph connection
The SIRIO medical device interfaces with the computerized tomograph for acquisition of DICOM medical images of a specific anatomic region.
For this purpose, the system implements a DICOM listening server with the following parameters:
AETitle SIRIOPort 104TCP/IP in accordance with the hospital's
Information System Service
To enable the connectivity, the system is fitted with an Ethernet socket located in the right rear panel (Image 1.33).A single preliminary intervention carried out by specialised tomographic system technicians is necessary in order to allow recognition by the SIRIO system.
Image 1.33: Ethernet data connection particular access point.
1.3.2 POSITIONING
Processing and display unit location
The processing and display unit can be placed at the physician's complete discretion, depending on monitor visibility necessities and available space.
Interaction between interventionist doctor and unit is extremely reduced and in any case limited to operations not strictly binding to normal intervention procedure, thus there is no constraint in the positioning of the unity.
The system can be placed in front, on either side of the bed opposite to the one the intervention procedure is being carried out, or placed laterally, toward the end of the TC bed(Image1.34).
When placing the unit, functionality provided by the carriage in total respect to ergonomics is taken into consideration. The working position can be customized according to the interventionist medic's hight (Image 1.35):
1. Adjust the top of the screen at about 2.5 centimetres below eyes level - release the brake and raise or lower the support as necessary.
2. Tilt the monitor in order to observe comfortably and reduce eye and neck strain.
3. Pull the headboard shelf towards oneself and position the case and the mouse support to the right or left, as necessary.
4. Work with the elbows at about 90° to reduce muscle fatigue.
5. Raise or lower the support until you reach the desired position.
6. Always keep the system loaded.
Image 1.34: Unit location in frontal position.
Image 1.35: Processing and display unit ergonomic positioning
Position sensor positioning
The proper position sensor placement is essential for the efficient use of the SIRIO system.
Sensor optimal placement requires a position height equal to about 2500 mm and the system's perpendicular will coincide with TAC bed's centre line.(Image 1.36). This position provides the best specialist tool visibility for intervention within the characteristic measurement volume (para. 1.2.2):
Several position system location configurations are available, depending on the particular support being used:
ceiling fixed upright mobile integrated on within he processing and
display unit
The choice of a particular configuration is entirely at the radiologist's discretion , and the result of the best compromise between the intervention room's space availability, minimum procedure interference and best specialist tool visibility for intervention within the characteristic measurement volume (para. 1.2.2):
Ceiling fixed sensorThis configuration maintains the work space to the fullest extent, guaranteeing a minimum
Image 1.36: Optimal position sensor positioning
Positioning sensor
footprint inside the room (Image 1.37).
Ceiling placement irrevocably constrains the position sensor's characteristic volume, preventing any change in measurement arrangement. This aspect might constitute a next image-guided navigation session limit, without clearly preventing correct execution.
The configuration arrangement requires specialist MASMEC staff preventive intervention. The personnel, during installation, will be careful to define all operations necessary for sensor's correct placement (Image 1.38).
Upright mobile sensorThe mobile configuration allows position sensor maximum manoeuvrability, resulting in, however, a minimal obstacle within the workspace.
The fundamental advantage of this configuration is the ability to modify the spatial location of the position sensor's characteristic measurement volume depending on the special needs arising during the intervention procedure.For this purpose, the position sensor is assembled in system's installation stage on an absolutely stable, high load capacity support.
The support is equipped with a hydraulic elevation system controlled through a pedal switch, making height adjustment very easy. By
Image 1.37: Celling positioning of the position sensor
Image 1.38: Celling positioning of the position sensor particularities
lightly pressing the pedal, the telescopic tubular structure can be elevated between 1850 mm and 2900 mm; by pressing the bottom of the pedal, a hight reduction occurs (Image 1.39).
The heavy 5 arm base grants stability to the support, while the 5 antistatic wheels allow an extremely easy movement. 2 wheels are equipped with brakes (Image 1.39).
The stand is equipped with a movable arm, allowing height adjustment, extremely easy position sensor extension and rotation.
Integrated sensorBecause the position sensor support is integrated on the carriage, a minimum space of the intervention room is occupied; the size of the system is reduced to just the processing and display unit.
The limitation of this configuration, it clearly is not binding for the correct execution of the intervention procedure. This limit is represented by the impossibility of independent manoeuvre
Image 1.39: Support base: foot control and wheels with brake.
Image 1.40: Movable arm movement range.
330 mmhight
Pivot 360°
Right / left rotation 180°
-5°
Inclination
+75°
Foot control
Wheel with brake
Wheel with brake
System displacement
Processing and display unit.
For normal transport, respect the following guidelines: (Image 1.41):
1. release the brake and adjust the work surface in the lowest position to ensure maximum stability and visibility;
2. close open shelves and place the mouse, and other accessories in their respective carrying cases;
3. unlock both front rotating wheels;4. Push the carriage from its rear while
keeping the elbows at about 90° to have maximum control and minimize muscle fatigue;
5. do not hurry. Before moving the carriage, make sure that the power cord is disconnected from the main power supply and safely hooked to the basket.
The position sensorPosition sensor's displacement on mobile support requires respect of the following indications:
1. adjust the telescopic rod hight to a minimum by operating the foot control;
2. retract the extension arm to reduce vibrations that could act upon the position sensor;
3. release wheel brake;4. move the support carefully paying
attention to the position sensor integrated cable connected directly to the processing and display unit.
Once the new support position has been defined, place the position sensor according to the instructions provided in par. 1.3.2.
In case of a carriage integrated support, the following actions are considered necessary:
1. adjust the telescopic rod hight to a minimum by operating the appropriate
Image 1.41: Processing and display unit movement
handles;2. retract the extension arm to reduce
vibrations that could act upon the position sensor;
3. move the overall system according to the indications pointed out in the carriage movement chapter.
WARNING For more detailed information related to the processing and display unit and the position
sensor movement refer to par. 1.6.
1.3.3 OPERATIONAL ENVIRONMENTAL CONDITIONS
1.3.4 SYSTEM POWER ON/OFF
The power on and off of the SIRIO system is achieved by pressing a key on the ignition interface (Image 1.42).
After a few moments, the SIRIO system will automatically start. The ignition procedure terminates when the SIRIO application splash screen is displayed. The system is then ready to receive data from the tomographic system.
The interface also allows UPS monitoring, indicating charge percentage with a series of red, yellow, and green lit or flashing lights. When the battery charge is under 50% maximum capacity, an audible alarm is emitted.
The switch-off is operated by the same button. At the end of the surgical session, properly close the intervention session (para. 3.9) by pressing a single button.
Image 1.42: System switch on
WARNING Do not connect/disconnect the electrical cable while the system is operational. If it is
necessary to turn on the unit just after the turn-off. Wait 2-3 minutes before turning on the unit.
Keep in mind that the battery must be recharged to the maximum capacity every day and that you can operate the carriage during charging, therefore leave the power cord connected to the power supply outlet as often as possible to avoid battery discharge.
Reload the backup drive as often as possible. Partial recharges do not affect battery capacity to reach the full charge and also prolong battery life.
Do not leave the system completely discharged for more than 3 months. If you do,the warranty will be considered void.
Do not leave the system completely charged and not used for more than 3 months. If you do,the warranty will be considered void.
1.4 SYSTEM FUNCTIONALITY
1.4.1 GENERALITIES
The main features of the SIRIO medical device are:
DICOM standard management
Switch on LED
Switch on/off button
two-dimensional three-dimensional imaging
real time navigation in a virtual 3D environment
intervention session recording and archiving
1.4.2 DICOM STANDARD MANAGEMENT
The DICOM (Digital Imaging and COmmunications in Medicine) standard defines communication, viewing, archiving, and printing criteria of biomedical information, such as radiology images.
The radiology images are displayed with corresponding tags. Simple image processing and distance measurement operations can be carried out.
1.4.3 TWO-DIMENSIONAL THREE-DIMENSIONAL IMAGING
SIRIO efficiently responds to the need of intra-operative image use in order to implement changes caused by intervention procedure or view the location of an intervention instrument.
SIRIO interfaces with the tomographic system in order to acquire two-dimensional images used for patient anatomy status recording. 2D images , however, lack significant information present in a three-dimensional model.
In conventional intervention methodology, in order to relate the changes highlighted in a two-dimensional image to a detailed 3D model , skilled practitioners need to merge pre-operative and intra-operative informationmentally, which may result a rather tedious task.
SIRIO, on the other hand, starting from a two-dimensional tomographic image provides a 3D reconstruction of the anatomic region of interest. SIRIO appropriately aligns the virtual area with the real area of a patient through appropriate automatic recording procedures. SIRIO arises as unique tool, assisting the radiologist with the surgical procedure
1.4.4 REAL TIME NAVIGATION IN A VIRTUAL 3D ENVIRONMENT
SIRIO is equipped with a three-dimensional rendering engine, this device constituting the heart of the virtual operating environment. In this device the three-dimensional model of the anatomic region in question an the three-dimensional model of the intervention instrument are uploaded. The device's maximum capacity is ten million polygons and the refresh rate is 20 frames per second. The engine allows real time real probe movement display, movement carried out during an intervention or diagnostics session regarding the respiratory system.
The rendering engine, besides intervention mode, can also be used in pure view mode. This mode is used for chest model view and to review probe displacement during a intervention or diagnostic session.
1.4.5 INTERVENTION SESSION RECORDING AND ARCHIVING
A patient's personal data information is stored in a database accessible only by SIRIO. The database contains all project names created for the patient. Each project is uniquely associated with an
archive containing the DICOM files of chest CT scans, proprietary format files containing treated organs, configuration files.
Together with the data acquired during the pre-operative phase, SIRIO is able to record and store on disk all information associated with any particular intervention. The intervention session is recorded in all its phases and stored within the system.
SIRIO grants access to session recordings at any time, displaying them on the monitor. The opportunity to review all virtual needle positions during the intervention session is another system particularity.
1.5 TECHNICAL SPECIFICATIONS
Processing and display unit
Powered carriage for LCD
Characteristic ValueDimensions See Image 1.43.Weight approximately 65kgPower supply 230 VAC, 50 Hz, single phase
66 Ah power supply system with two (2) 33 Ah batteries, 12V DC.
Certification EN e IEC 60601-1EN 55011 A Class (CISPR 11)EN 55024
Image 1.43: LCD powered carriage overall dimensions.
LCD monitor
Characteristic ValueDimensions 506 x 444 x 119 mm (L x A x P) (Image 1.44)Weight approximately 9.8 kgPower consumption Maximum: approximately 100 W
Standard: approximately 92 WPower supply From 100 to 240 V AC ± 10 %, 50/60 Hz,
single phase (multiple socket power supply inside the carriage).
Input signal VGA connectorCertification EN IEC 60601-1.
Image 1.44: Overall monitor dimensions.
Acquisition and processing unit
Characteristic ValueDimensions 378 x 49 x 309 mm (L x A x P)Weight approximately 4 kgPower supply 230 VAC, 50 Hz, single phase
A.C. adaptor 150 WCertification Compliant with safety and reference
electromagnetic compatibility standards.
The position sensor
Sensor
Characteristic ValueDimensions 613 x 104 x 84 mmWeight 1.9 kgInput voltage 26 VDCPower consumption 13.5 WLaser class 2Laser wavelength 635 nmMaximum power 1mWStandard laser - ANSI Z136.1
- IEC 60825-1- FDA/CDRH 21 CFR 1040.10 and 1040.11
Certification EN 60601-1EN 60601-1-2EN IEC 60825-11999/5/EC – R&TTE Directive
USB converter
Characteristic ValueDimensions 88 x 57 x 39 mm
Weight 0.35 kgInterface USBInput voltage 24 VDCOutput voltage 26 VDCPower consumption < 2W
Power supply adaptor
Characteristic ValueDimensions 125 x 62 x 32 mmWeight 0.37 kgInput voltage 100 VAC to 240 VAC, 50/60 Hz26 VDCOutput voltage 24 VDC @ 2.1 APower consumption 50 W (max.) (24 W typical)
System precisionSIRIO's accuracy is described as the difference between the position of the sensitized real needle tip and the tip of the image-guided virtual needle.This difference produces a position error per length unit starting from the patient sensor unmarked sphere (Patient tool). The position error is always visible to the operator and depends on the tomographic scan's axial resolution: the error is inversely proportional to the axial resolution.Apart from the mistake committed by source equipment on data processed by SIRIUS, in conditions of rigid bodies and axial resolution scans smaller or equal to 1.5 mm, the positioning error satisfies the following inequality:
where the distance 100 mm should be measured from the ball not marked by the Patient tool.
1.6 SYSTEM PACKAGING, STORAGE AND TRANSPORT
Information regarding system manufacturing, storage and transport is listed below. Security alerts, concerning the two macro components composing the system: the processing and display unit and the position sensor are also listed below.
1.6.1 PROCESSING AND DISPLAY UNIT
For the processing and display unit packaging and transport, the LCD monitor must be removed from the carriage tower of the and warped in its original packaging, taking all the necessary precautions to avoid mechanical stress. The carriage must be carefully wrapped in a bubble packaging paper, appropriately secured and transported under the following conditions:
Both swivel wheel bakes locked;
completely folded equipment: all the open shelves must be closed, mouse, and other accessories placed in their cases.
For normal transport, respect the following guidelines:
release the brake and adjust the work surface in the lowest position to ensure maximum stability and visibility;
close open shelves and place the mouse, and other accessories in their respective carrying cases;
unlock both front rotating wheels;
Push the carriage from its rear while keeping the elbows at about 90° to have maximum control and minimize muscle fatigue;
do not hurry. Before moving the carriage, make sure that the power cord is disconnected from the main power supply and safely hooked to the basket (Image1.45).
Processing and display unit storage requires two different procedures depending on the period when the system is taken out of order.
Short term storage
If the power supply system will remain inactive for no more than three months, the batteries must be recharged at maximum capacity before being stored.Short term storage procedure means:
1. turning off the LCD monitor;
Image 1.45: Processing and display unit transport
Image 1.46: Step 1: turn off the monitor.
2. connecting the power cord (Image 1.47) to a power outlet in order to charge the batteries to 100% - all of the lights will lit up - Image 1.48. The batteries must be recharged at maximum capacity before storage;
3. Turn off the system by holding down the appropriate button for 1 - 3 seconds(Image 1.49);
4. set both battery switches to OFF (Image1.49).
Long period storage
If the power supply system will remain inactive for three months or more, the batteries must be removed from the carriage and preserved. The 4 step illustrated procedure in case of short period storage is similar, but the following steps are to be added:
5. Disconnect the battery terminals, paying attention to first unplug the black (-) and then the red ( +) (Image 1.50);
6. Store batteries in a cool, dry place. The optimum storage temperature is 15 °C.
Image 1.47: Step 2: connect the power cord.
Image 1.48: Step 3: 100 % charged batteries indication.
Image 1.49: Step 4: disconnect the batteries.
Image 1.50: Step 5: disconnect the battery terminals
ATTENTION: disconnect the black wire (-) before disconnecting the red one (+ ).
WARNING: Do not remove or install batteries while the carriage is located in an environment rich in oxygen, because it is dangerous. Sparks may be generated.
1.6.2 POSITION SENSOR
The position sensor can be transported and stored in the pressure, humidity and temperature range presented in Table 1.1.
Table 1.1: Position sensor transport and storage environmental conditions.
Characteristic Value rangeAtmospheric pressure p 50 kPa p 106 kPaRelative humidity h 10% h 90%Temperature T -10°C T +50° C
ATTENTION The relative humidity range is meant in the absence of condensation.
ATTENTION The position sensor transport must be placed back in the original packaging and all necessary precautions taken to avoid mechanical stress. Failure to do so may expose the sensor to excessive mechanical stress and affect device calibration. While continuing to operate, the sensor could provide inaccurate position measurements, putting patient safety at risk.
ATTENTION Do not carry or keep the position sensor in environments characterized by different environmental conditions than those specified. Failure to follow this precaution could affect device calibration. While continuing to operate, the sensor could provide inaccurate position measurements, putting patient safety at risk.
1.7 MAINTENANCE AND SECURITY
System cleaning and maintenance information is listed below. Security alerts, concerning the two macro components composing the system: the processing and display unit and the position sensor are also listed below.
1.7.1 PROCESSING AND DISPLAY UNIT MAINTENANCE AND SECURITY
Cleaning and maintenanceThere is no guarantee that the following procedures will prevent infections. It's necessary to consult a epidemiologist or hospital administrator responsible for antiseptic procedures.
Do not expose electrical components to water, detergent solutions or other liquids or potentially corrosive substances to prevent the risk of electric shock.
Do not immerse the carriage or its components in a liquid, and avoid liquid flow on the carriage. Immediately clean traces of detergent from all surfaces with a damp cloth. Thoroughly dry the surfaces after cleaning them.
Do not use flammable detergents on carriage surfaces because of their closeness to devices and electrical components.
All the carriage's plastic and painted components tolerate most commonly used cleaning solutions as long as they are diluted and non-abrasive. Such solutions as: of ammonia quaternary compounds, products based on ammonia, bleach or alcohol.
• The surface of the monitor can be cleaned with 50% to 70 % concentrated isopropyl alcohol;
• The marks left by pens and permanent or erasable markers can be removed with isopropyl alcohol to 91% and a soft cloth.• The iodine tincture stains can be removed with a commonly used detergent and a soft cloth.• Never use steel wool or other abrasive material, which would damage surface finishes or the monitor surface.• Do not use strong solvents such as trichloroethylene and acetone. These solvents will damage the finish of the surface.Preferably test any cleaning solution on a small, non visible area to make sure that the surface cannot be damaged.
Swivel wheelsCheck wheels periodically to make sure that they are clean and free from materials that would hinder their regular movement. Avoid moving the carriage on irregular, dirty, or damaged surfaces.
Adjustments, repairs and replacements DO NOT attempt to adjust, repair or replace any processing and display unit parts. Only MASMEC can adjust, repair or replace system components. If a processing and display unit component is missing or damaged, do not use the system and contact MASMEC customer service immediately requesting a replacement.
Maintenance and periodic inspections
Component Operation Frequency On who's behalf
UI, ALD, Ethernet, USB cablesCheck if they are worn or crushed, or if the connectors are damaged
Each month Any user
Swivel wheels Check for signs of wear or if dirty Each month Any user
Maximum loadMake sure that specified maximum loads are not exceeded
Each day Any user
System SLA power supply battery
Replace lead-acid batteriesWhen the system indicates it, or when the remained maximum battery life is half the original
MASMEC
Power supply moduleCheck air intake slot for dust and clean, if necessary, with a vacuum cleaner.
Each month Technical personnel
Battery cableCheck if worn or crushed, if the sheath is cracked or damaged in any other way
Each month Technical personnel
Spiral cableCheck if worn, overstretched or damaged. Move the hook holding it, to avoid cable drag on the floor
Each weak Any user
Positioning sensorCheck the position sensor's calibration
When you have reason to believe that the sensor has suffered mechanical and environmental shocks.
MASMEC
Processing unitCheck memory availability on hard disk.
Each month Any user
Processing unit Store data provided by the system.When hard disk memory availability is less than 20%
Technical personnel
Security alerts concerning the Processing and Display Unit
PLEASE NOTE: Failure to follow these guidelines may result in equipment damage or injury.
ATTENTION: the vertically adjustable brake of the support stabilizes the work surface and the keyboard shelf but it does NOT increase weight support cacacity. Do not load the support with a apparatus of overall weight greater than the specified range.
ATTENTION: do not use the system with missing or damaged parts. Do not remove, modify, or replace system components without first consulting MASMEC. If you encounter problems during installation or use of the system, please contact customer service MASMEC.
WARNING: danger arising from stored energy. The lifting mechanism of the work surface is under tension and moves quickly as soon as stored equipment is removed. For this reason, do not remove any equipment unless the work area has been elevated to highest tower position. Failure to do this can cause serious injury and/or damage to equipment. If he system must shipped, adjust the lifting mechanism of the work surface to a minimum voltage (at the top of the tower).
ATTENTION: do not loosen, tighten or remove the screws and nuts located on the height adjustable support or on the carriage tower upper region. If the screws or nuts are tempered with, the carriage becomes unstable and consequent damage to equipment and/or injury will occur.
Not to pass the cable through doors, ceiling, walls or floors empty slots.
FULLY INSERT the plug into the socket.
Keep away from water. DO NOT USE IF WET.
Keep the cord out of the reach of children.
Do not connect the power cord to additional power strips or extension cables.
AVOID OVERHEATING. Unwind the cable and do not cover it with another material.
Do not push, drag, or place objects on the cable.
Do not walk on the cable.
GRASP THE PLUG to remove it from the socket. Do not disconnect by pulling the cord.
ATTENTION: Thoroughly inspect SIRIO power supply cable before use, DO NOT USE THE CABLE IF DAMAGED.
Release the lifting mechanism brake before moving the work surface; if the surface moves while the brake is on, serious damage could be caused to SIRIO carriage's lifting mechanism.
Do NOT expose the SIRIO carriage to direct sunlight, high electromagnetic fields and excessive mechanical vibrations.
Do not block or cover the ventilation fan. Is necessary for the processing unit ventilation.
Do not subject the system to a supply power greater than that specified.
1.7.2 POSITION SENSOR MAINTENANCE AND SAFETY
Cleaning and maintenancePosition sensor maintenance is limited to the following procedures: Sensor cleaning Cables and connector status inspection
Do not expose the sensor to water, detergent solutions or other liquids or potentially corrosive substances . Any above mentioned substance infiltration into the device could cause electrical shock and irreversible system damage.
The maintenance tasks must be carried out by suitably trained personnel in order to avoid the risk of electrocution.
Do not sterilize the position sensor since this may cause irreversible damage to the device. While continuing to operate, the sensor could provide inaccurate position measurements, putting patient safety at risk.
The position sensor, in particular the light filters and the lenses should be cleaned only if necessary. Cleaning frequency should be established by the operator.
• Only Use 70% isopropyl alcohol or solutions for the lens cleaning (example: AR66).• Remove the dust from each light filter and lenses using a photographic lens brush.• Gently clean light filters and lenses using a cotton cloth soaked in above mentioned detergents.
Position sensor safety notice
PLEASE NOTE: Failure to follow these guidelines may result in equipment damage or injury.
ATTENTION Do not use the position sensor in flammable materials presence such as anaesthetics, detergents and solvents. Failure to do so may result in fire, injury and death.
ATTENTION the radio frequency communications equipment can alter position sensor's performance. While continuing to operate, the sensor could provide inaccurate position measurements, putting patient safety at risk.
ATTENTION Do not look into the laser emitter outlet. The class 2 position sensor's laser module emits visible radiation capable of damaging the human eye. By looking directly into the laser emitting diode may cause permanent eye damage.
ATTENTION Make sure that patients with reduced reflexes or mobility (for example patients subjected to medical procedures) do not look into the laser emitter outlet. By looking directly into the laser emitting diode may cause permanent eye damage.
Do not place heavy objects on top of the processing and display unit position sensor's cable
connection.
Do not drag on the floor the processing and display unit position sensor's cable connection.
Do not force connection or able connector removal from the position sensor.
1.8 DISPOSITION
All of the components bearing this symbol must be disposed of in accordance with local health authority dispositions.
2 SECTION 2: OPERATOR INTERFACE
2.1 INTRODUCTION
The SIRIO operator interface software consists of a main frame containing the panels including system and display function keys In Image 2.51 is shown the SIRIO main frame, containing the following components:
main menu working folder panel session explorer main toolbar caption bar visualization panel posture tracking bar breathing tracking bar image explorer status bar
Each of the above mentioned components is analysed in detail in subsequent paragraphs.
Image 2.51: SIRIO's main frame.
WORKING FOLDER PANELMAIN TOOLBAR
TOOL PANEL TOOL BUTTON
SESSION EXPLORER
SESSION TREE
STATUS BAR
IMAGE EXPLORER
VISUALIZATION PANEL
CAPTION BAR
POSTURE TRACKING BAR BREATHING TRACKING BAR
2.2 MAIN MENU
SIRIO's main menu (Image 2.52) is able to manage the sessions associated with patients and individual documents, the latter represented by DICOM images in tomographic scan format.From the user's main menu, one of the following items can be selected:
Browser: opens the patient browser and the sessions associated with them;
Close Session: closes a session associated with a patient;
Open File: opens desired file
Close File: closes desired file
Search: searches through the workbook;
Exit: close SIRIO;
Recent Documents: openes une of the four most recent documents.
Image 2.52: SIRIO's main menu
NOTESome selections (Browser, Close Session, Search) can be found on the main toolbar and are analysed below.
2.3 WORKING FOLDER PANEL
The working folder is a windows directory in which all patient data and projects associated with those patients are stored . A working folder sett-up is performed by selecting Search from main menu or from working folder panel (Image 2.51). This action produces the opening of the window Image 2.53, from which working folder can be selected. The new folder path appears in the working folder panelbox , also containing previous workbook relative paths.
Image 2.53: Folder selection window.
2.4 FOLDER SELECTING WINDOW
The Session Explorer is the main frame panel containing the data tree structure. The data tree structure organizes data related to an intervention session.The structure contains 4 levels: Session: main level; Position: each position is relative to patient's
position on the diagnostic unit bed; Series: each series, assigned to a position,
consists of a scan package related to an anatomical region;
File: represents the last tree level, and symbolizes a slice of the scan in DICOM format .
Image 2.54 Session Explorer.
NOTE DICOM files are the only structural elements that can be dealt with collectively, while the software allows individual session, position and series handling.
2.5 MAIN TOOLBAR
The SIRIO main toolbar is composed from the following tool panels gathering the system's main functionalitie keys:
session panel view panel image tools panel volume panel registration panel volume rendering panel users panel system settings panel
In subsequent paragraphs, a detailed description of each panel is provided.NOTEThe system settings panel is displayed only when the user level is power user or administrator.
2.5.1 SESSION PANEL
The session panel (Image 2.55) combines all SIRIO functionality necessary for a intervention session execution.It is organized according to a series of sub-panel, each relating to a phase of the intervention session. Each sub-panel, in turn, is composed of one or more function keys. Patient and SessionThis sub-panel (Image 2.56) contains browser
Image 2.55: The Session panel.
and close operation keys. The browser key opens the patient and related sessions management window, while the close key closes an active session.In Image 2.57 is shown the session browser patient and related sessions management window. A Patients table can be distinguished, containing patient names, and a Sessions table, containing session names associated to patients The New and Delete keys of the two sections allow element adding or deletion from corresponding tables. In particular, the New – Patients key opens a brief patient personal data information (Image 2.58), while the New – Sessions key attaches a name to the newly created session (Image 2.59).A session can be opened by selecting the corresponding row in the Sessions table and pressing OK, or by positioning the mouse pointer over the table row and double clicking the left mouse button. This action displays the tree structure related to that session in session explorer (Image 2.54). Position and SeriesThis sub-panel(Image 2.60) contains the necessary functionality needed to modify session structure, insession explorer:- Add Position: creates a new position within
the structure, queued last; the name of the new item is position XX, where XX is a progressive number of a unit with respect to the value of the last position;
- Delete Position: eliminates the position selected from the session's structure;
- Add Series: causes a new series creation within the structure, within the selected position and right after the last series. Selecting this button causes Image2.53window opening. The key is used to select the folder containing the DICOM scan files.
- Delete Series: eliminates the selected position from the session structure.
Image 2.56: The Patient and Sensor sub-panel
Image 2.57: The Session Browser.
Image 2.58: Patient's personal data information
Image 2.59: Session name allocation.
Image 2.60: The Position and Series sub-panel.
NOTE- The session panel keys have different enabling status: when a feature can not be explained, in a
given system status, the corresponding key is disabled.- Every session panel key can be selected using the mouse or the keyboard, by pressing the icon
button indicated in parenthesis, (example: Add Position may be selected using the F3 key from the keyboard);
- When selecting the delete position and delete series keys, a window is opened informing the user that all data related to that structure will be deleted and asks for confirmation.
WARNINGThe selection of a folder (Image 2.53) containing no DICOM files, after the decision to add a series (Add series) to a determined position has been made, produces an error code informing the user about the system's inability to load a DICOM file.
RegisterThe Register sub-panel(Image 2.61) contains the basic functionality for SIRIO operation. Patient registering (Patient) allows a faithful reproduction of real needle displacement with reference to the anatomic region of interest, within SIRIO virtual environment.The Patient key register a series of slices, therefore, is enabled a only if asession explorer series is selected or one of the DICOM files contained in it.By selecting the Patient , an user transparent procedure will be initiated, however, a progress bar will give information about progress status (Image 2.62). At the end of patient registration the status bar is updated by the SIRIO main frame (Image 2.51) indicating registration and product error, expressed in millimetres, each 100 mm starting from patient tool's centre of gravity (Image 2.63).A further colour indicator lights up green if the error product is lower than a pre-established machine threshold (whose value can be changed only by technicians). The colour indicator lights up red (Image 2.64) if the error has exceeded the threshold is in fact a series of slices was not recorded.By selecting different sets, the status bar is updated based on related registration data. (Posture) panel high functionality allows patient posture recording by selecting the corresponding key, meaning different marker posture position are recorded with respect to the patient tool. The effect of this selection is identical to the Get key of the Posture Tracking Bar (par. 2.8):
Image 2.61: The Registration sub-panel
Image 2.62: Patient registration procedure progress bar.
Image 2.63: Patient registration procedure results.
Image 2.64: Unregistered series and valid series registration.
NOTEPatient registration is a procedure performed automatically by the system as a standard operation during an intervention procedure (para. 3.7):
WARNINGPatient registration may produce a high error or fail (para. 3.7):In this case the user is asked to perform simple interactions on a window that automatically opens when above mentioned eventuality occurs (Image 2.65). In particular, we need to seek and select with the left mouse button four markers from the slices constituting the series, each represented by
the image of a small 2.5 mm diameter metal sphere, that produces a yellow patch when selected(Image 2.66). The right mouse button deselects the marker, thus the the yellow patch disappearance.The marker status acquisition (Image 2.67) remind the user the number of acquired markers and the number of markers to acquire.
Image 2.65: Patient manual registration window.
Image 2.66: Marker selection.
Image 2.67: Marker acquisition status.
Image 2.68: Inaccurate marker acquisition notification window
The reset key allows previous marker acquisition reset at any time all, while the register key is active only when all four markers are selected. When the four marker acquisition is completed, the user must select the register key and then apply.
Marker manual selection is an operation that must be performed with care, in order to avoid common acquisition inaccuracy (Image 2.68). In this case, it's mandatory to repeat markers acquisitions. In case the system accepts the manual marker acquisition error it is also possible that, by selecting the register key, the error committed by the registration algorithm will have a high value (bigger than the pre-imposed machine threshold) so it's not accepted and does not enable the apply key. In this case the alternative is to repeat marker acquisition or exit the procedure.From now on, it will be highlighted that the correct registration of a slice series represents a necessary requirement in order to be able to access SIRIOS system's advanced features.
3D SessionThe 3D Session (Image 2.69) sub-panel contains SIRIO's most important feature. By selecting the tracking session key, the three-dimensional virtual environment opens. Here the anatomic region of interest reconstructed from slices that constitute a series can be found. The intervention needle can also be accessed from here.In order to enable this button, two conditions must me met:- a series or in one of the implicit DICOM
files must be selected- the series must be correctly registeredthe Image 2.70 shows SIRIO's virtual environment window, in which one can distinguish, by default, three display panels.
Image 2.69: THE 3D Session sub-panel
Image 2.70: SIRIO's three-dimensional virtual ambient window.
- 3D visualization panelThis panel shows the three-dimensional reconstruction of the anatomic region that provided the acquired scans.The point of view is located on the needle axis and can slide along sing the dialpad buttons Pag (zoom in) and Pag (zoom out). A cutting plane situated in the virtual needle tip is also perpendicular to the needle. The cutting plane enables the display of the 3D reconstructed section. The section is reconstructed form the downstream plan;
- Pseudo axial visualization panelThis panel displays the 3D section reconstruction generated by a plan connected to the needle and also parallel to the body's transversal axis (Image 2.71);
- Pseudo axial visualization panelThis panel displays the 3D section reconstruction generated by a plan connected to the needle and also parallel to the body's longitudinal axis (Image 2.71);Above the three display panels, a button and
Image 2.71: Body's main axis.
indicator bar can be found.Starting from the left, the acquired series registration status and the relative error are displayed. The distance in millimetres between the needle tip and relative patient tool is also displayed.Follows the length indication of the last acquired sensor needle (in millimeters).When the virtual environment is opened, if no needle has been acquired, the above mentioned indicators assume the appearance shown in Image 2.72, while if the needle has been acquired in a previous session, although occupying to the same position, the system will notify as if it was an old acquisition (Image2.73).Finally we'll emphasize button features and their meaning and other indicators located on the bar.
- Breathing trackingThe meaning of the indicators of this window and its features are dealt with in paragraph 3.4.2.
- Posture trackingThe meaning of the indicators of this window and its features are dealt with in paragraph 2.8.
- TrajectoryBy selecting this button a video connection is implemented. It's appearance resembles a red line and is composed by the rectilinear trajectory chosen by the radiologist (para. 3.8.2):
- ViewsBy selecting this key repeatedly, the virtual environment aspect will change in terms of display panel number.The default aspect shown in Image 2.70 switches to the only two two-dimensional views (Image 2.74) and to the only three-dimensional display panel (Image 2.75).
- WindowingBy selecting this button, the display window of the pseudo-axial and pseudo-sagittal windows can be changed; you can choose between the default, pulmonary and mediastinal windows(Image 2.76).
Image 2.72: Needle not acquired.
Image 2.73: Needle acquisition not updated
Image 2.74: Only two-dimensional panel display
Image 2.75: Only 3D panel display
- Manual needle registrationBy selecting the manual key, the sensor needle will start manual recording ( Image 2.77).With respect to the automatic procedure (para. 3.8.1), the procedure that acquires the needle and then the operator hovers the needle tip for a few seconds over one of the J,K,L markers points, the manual procedure requires that another operator to select the get key (two operators).All needle tip positioning inaccuracies on a marker point and inflexions produced by the hand of the operator are detected in real time and shown in terms of resulted deviation. A small deviation foreshadows a precise registration of the intervention needle. Small deviations are indicated by a green bar, which gradually becomes yellow or red when the deviation increases (Image 2.77).You can switch to automatic or manual mode at any time.
Image 2.76: Display window selection
Image 2.77: The sensor needle's manual acquisiton interface
NOTE- SIRIO's virtual ambient opening is performed automatically by the system as a standard
operation during an intervention procedure (para. 3.7);- The acquisition of a sensor needle is bound to a particular session position. All of the series
below refer to the same virtual needle;
WARNING
- If the selected series has not been correctly recorded the virtual environment of SIRIO cannot be started, either manually through the (tracking session key (Image 2.69), nor automatically during system standard operation of an interventio procedure.
- In case the virtual environment is already opened and automatic registration fails during a series update forwarding (para. 3.8), the system assumes the following state:
the virtual environment remains active with the latest 3D reconstruction registered correctly;
the user is notified that the registration has failed and that he's using the last valid registration (Image 2.78).
Image 2.78: Patient registration fail notification
If the patient has undergone displacements with respect to the last correctly recorded position,
forwarding a new slice series is recommended in order to avoid virtual needle position and orientation errors with respect of the real needle;
- Sensor needle's manual registration is an emergency procedure. This should be implemented when the system is unable to start automatic registration, however, it is always recommended to identify the causes that prevent SIRIO to initiate the automatic procedure of registration rather than proceeding immediately to manual mode. Possible causes are:
rough sensor needle's tip positioning of on one of the J,K,L marker points ; excessive needle flexion caused by operator's hand when placing the tip on one of the
marker points; incorrect optical sensor positioning on the intervention needle;
2.5.2 VIEW PANEL
The view panel (Image 2.79) assembles 4 check boxes that allow display or hide the following visualisation panels of SIRIO's main frame :
- Session Explorer- Image Explorer- Status Bar- Tracking Bar
The IDL Output panel is only activated by superior entry to user level.
Image 2.79: The View panel.
2.5.3 IMAGE TOOLS PANEL
The Image Tools panel contains some basic image processing features, available only when a document is opened (DICOM file):
- Flip: horizontally capsize the image;- Rotate left: rotate the image 90° to the left ;- Rotate right: rotate the image 90° to the
right;- Zoom in: enlarges the image with 100 %;- Zoom out: reduces the image with 100 %;- Ruler: measure the distance between two
image points (in mm);- Colour table: edit the table of the colours
associated with the image.
The flip, rotate and zoom features can be enabled by simply pressing the corresponding button, while in order to measure the distance between two points of an image, it's necessary to move the mouse pointer onto the first point, press the left mouse button and drag it onto the second point. You'll see a line uniting the first and the second point and the relative length measurement in mm. The measurement will change in real time along with the mouse movement. The line then adopts a length and a fixed position when the left mouse button is released (Image 2.81).By pressing thecolour table key, a menu will open. This menu contains image thumbnails related to different colour table (Image 2.82). By selecting one of the 8 alternatives, a new colour table will load and the image will have the corresponding colour (Image 2.83).
Image 2.80: Image tools panel
Image 2.81: Measurement of the distance between two points.
Image 2.82: Colour table.
Image 2.83: Colour table loading
2.5.4 REGISTRATION PANEL
The registration panel replicates patient and posture acquisition recording capabilities, capabilities also present in the registration sub-panel from the session panel (para. 2.5.1):
2.5.5 VOLUME RENDERING PANEL
The volume rendering (Image 2.84) panel offers three different modes for SIRIO virtual environment opening:- Tracking session- Playing session- Viewing sessiondescribed in detail below.
Tracking sessionThe tracking mode was already described in the sub-panel 3D session of the panel session (para. 2.5.1):
Playing sessionIn this mode the virtual environment of SIRIO offers the opportunity to review all of the positions taken by virtual needle in a previous intervention session. (Image 2.85) shows the aspect of virtual environment playing mode.
Image 2.84: Volume rendering panel
Image 2.85: SIRIO virtual environment in playing mode.
At the top of the window there is a front panel with the classical functions of a media player (Image 2.86):
- start- fast backwards- play- fast forward
Image 2.86: Player connection panel.
- stop
and a progress giving the possibility to jump to any sequence point.
Viewing sessionIn this mode the virtual environment offers the possibility to view the three-dimensional reconstruction of the scanned anatomic region, starting with the series of slices selected in session explorer session explorer (Image 2.87).With the left and right mouse buttons, you can move the point of view in order to navigate within the reconstructed 3D space.
Image 2.87: SIRIO's virtual environment in viewing mode.
NOTEThe functionality playing session of volume rendering panel is enabled only if the virtual environment, for the selected series, was opened at least once in tracking mode.
2.5.6 USERS PANEL
The Users (Image 2.88) panel manages the three possible SIRIO user levels:
- user- power user- administrator.
Compared to the levels power user and administrator, the user level cannot access any system configuration functionality. The administrator level has access to all functionality configurations, some of which are also precluded to power user.
The default user level is user, while the access to the other two levels requires password insertion. Image 2.89 shows the menu that opens by pressing the login button from users panel. By selecting the Administrator (Power User) entry, the window for password entry is displayed (Image 2.90).
Selecting Logout involves leaving the administrator (power user) level and returning to the default level. In order to change password, press change Password. In this case you must enter your old password, type a new and verify (Image 2.91). Unless otherwise advised, always refer to user level accesible features.
Image 2.88: User panel
Image 2.89: Login menu
Image 2.90: Password input window.
Image 2.91: Password change window.
2.5.7 OPTIONS PANEL
The options panel (Image 2.92) offers the ability to vary certain graphic parameters and some voice command activation.By selecting the Colours allows virtual needle colour change (Image 2.93) and representation modes variation. The preview feature is update every time a parameter is changed.By selecting Views you can choose a default setting from one of the three rendering window configurations (Image 2.94).Finally, the Voice Commands key activates the following voice commands:
- FIX : fixes the insertion trajectory (equivalent to trajectory key);
- EXIT: exits from the virtual environment;
Image 2.92: The options panel.
- FRAME: change the rendering window configuration (equivalent to Views key);
- POSTURE: adjusts the patient's posture (equivalent to get key from the postures tracking bar).
Image 2.93: Colour selection and virtual needle representation mode selection.
Image 2.94: Rendering window configuration selection.
2.6 CAPTION BAR
SIRIO' main frame caption bar shows the patient's name when a session is opened.
Image 2.95: Caption bar.
2.7 VISUALIZATION PANEL
The visualization panel is the document display panel. A SIRIO document is represented by a DICOM file, a standard that defines the communication, display, archiving and biomedical information printing criteria.A DICOM file consists of a graphical part, the tomographic image, and a data (tag) series containing patient information, type of conducted analysis, image resolution and more.Both of these aspects of a DICOM file are displayed in the visualization panel through two sub-panels:
- image panel- tag panel
The first is shown in Image 2.51, the second in Image 2.96: The TAG sub-panel
Image 2.96.
NOTE- Files that used currently by SIRIO have a .dcm extension (DICOM file);- A file can be opened from the main menu (Image 2.52) by selecting open file, or by double
clicking one of the session tree (Image 2.52)files or on one of the images from of image explorer (par. 2.8):
2.8 POSTURE TRACKING BAR
The posture tracking bar (Image 2.97) is a panel present in SIRIO's main frame and in the virtual environment bar of (Image 2.70). This panel is dedicated to patient posture monitoring during an intervention session.Patient posture acquisition is determined by defining the patient's most suitable intervention position, by applying 3-4 (maximum 5) posture markers (Image 1.8), constantly displayed by the circular LED and by selecting the Get key. This action separates the input standby phase of from the subsequent monitoring phase, indicated by the posture deviation bar. The bar is coloured green, yellow or red if the difference between patient's position and acquired position is a few millimetres (Image 2.97), a few millimetres over one centimetre (Image 2.98), a few centimetres (Image 2.99).When current posture deviation is to high in relation to acquired position, the system notifies references loss, therfore the impossibility to provide an offset assessment (Figure 2.100).
Image 2.97: Posture tracking bar
Image 2.98: Approximately 1 cm deviation
Image 2.99: A few centimetre deviation.
Figure 2.100: Considerably deviated posture.
NOTE- The reflective markers applied to patient's skin and posture monitoring assets, need not all be
visible to the main sensor: medical staff manoeuvres may sometimes occlude one or more markers. Clearly, deviation indication is more accurate when the visible marker number is greater and when their placement is closer to initial posture position, position provided in the acquisition phase (Get key);
- in the acquisition phase all postural markers must be visible to the main sensor;- if some reflective markers come into play after the acquisition, the system does not recognize
them as markers and postural interference signals. In this case it is necessary to repeat the acquisition by comparing the number of markers involved with the number of green LEDs lit;
- Posture acquisition must be carried out immediately, before the start of the tomographic scan, when the patient's position on the bed is well determined.
2.9 BREATHING TRACKING BAR
Paragraph 3.4.2 provides a detailed description of the breathing tracking bar, which is the panel member assigned to patient's respiratory activity monitoring during a intervention session, present in SIRIO's main frame and in the virtual environment bar.
2.10 IMAGE EXPLORER
The image explorer (Image 2.51) is a display panel that shows a TAC scans series preview and related dimensions. The panel will update according to session explorer. selected series. In addition to the mere display function, you can interact with the images to open one or more documents by double clicking an image.
2.11 STATUS BAR
The status bar is a SIRIO main frame panel (Image 2.51) containing a set of system status indicators and of currently open session indicators.Starting from the left, the first indicator is related to the main optical sensor status. Consists of three optical sensor possible images (Image 2.101):
- disabled- enabled and not tracking- enabled and tracking
Follows the indicators relating to the slice series registration status, whose significance has been already shown in para. 2.5.1 , Image 2.63 and Image 2.64.Starting from the right, status indicator of SIRIO-tomograph connection is presented (Image 2.102).Follows the user level indicator. Consists of three user possible images (Image 2.103):
(a) disabled
(b) enabled and not tracking
(c) enabled and tracking
Image 2.101: Main optical sensor status indicators.
(a) siconnected (b) connected
Image 2.102: SIRIO-CT connection indicators
- user- power user- administrator
Finally, the TAC scan receiver status indicator:- receiver not ready: SIRIO cannot receive
images from TAC.- Testing port: SIRIO is verifying that there if
the reception port contains qued images.receicer ready: SIRIO is ready to receive DICOM images.
- receiving slices: SIRIO is receiving images from TAC.
Consisting of the three images of Image 2.104.
(a) user (b) power user (c) administrator
Image 2.103: SIRIO user level indicators
(a) receiver not ready
(b) receiver testing port
(c) receiver ready
(d) receiving slices
Image 2.104: TAC scan receiver status indicators.
3 SECTION 3: THE INTERVENTION PROCEDURE
3.1 INTRODUCTION
This section's purpose is to illustrate the operational procedure normally observed during biopsy and thermoablation interventions carried out with the help of the SIRIO system.The intervention session is usually characterized by a succession systematic and well-defined procedures prior to intervention on one hand, and intra-operative procedures on the other. In particular, the following steps can essentially be distinguished:
intervention instrument preparation patient positioning applying sensors on the patient tomographic scan scan result loading patient registration image-guided browsing session
In the following intervention procedure illustration, at the beginning of each phase a comment is displayed, adapted to provide general information about the purpose of the step itself. Each step is described by associating a related image; printed data is related each SIRIO screens and must be considered as examples, being values dependent on an individual patient and the related procedure.In case of particularly important indications and precautions and/or any required procedures in case of SIRIO system operation outside of typical intervention procedure, such information will be suitably highlighted according to the conventions used in this manual.This section is dedicated to the operator as a guide to correct system utilisation.
3.2 INTERVENTION INSTRUMENTS PREPARATION
3.2.1 THE INTERVENTION KIT
The kit selection is closely linked to biopsy needle or thermal ablation characteristics used in a particular intervention procedure.The detailed intervention needle specifications to keep in mind are:
insertion connector (Image 3.105): this connector constrains the specialised Needle Tool selection. A well-defined code uniquely identifies the particular type of specialised intervention kit (with this purpose see the product code tables listed in appendix 4.3).
calibre (Image 3.106):The intervention needle' gauge determines the needle support (para. 1.2.4):
Image 3.105: Biopsy needle insertion connectors.
Image 3.106: Needle caliber - support compatibility.
WARNING When selecting the intervention needle length that is going to be used, you should take
into account the support length is 4 cm. Otherwise, the needle will not reach the intended destination.
Carefully review the intervention kit of before using it and check if damaged. Check if the sterile packaging is damaged.
The system is designed to be used only on one patient. Kit components are disposable. Do not reuse or re-sterilize. The system must be stored in a dry, fresh and dark place.
After use, the kit may become a biological hazard. It must be treated and disposed of according to normal medical practice and local and national applicable regulations.
3.2.2 KIT ASSEMBLY
This preliminary phase consists of two distinct operations.
1. Intervention needle assembly in the Needle Tool (Image 3.107).
The specialised kit being defined, introduce the intervention needle in the Needle Tool, following the package's use instructions.
2. Direction Tool mounting on the needle support
Assemble the tool on the support, by
Image 3.107: Intervention needle sensing.
introducing the insertion section into the star shaped joint (Image 3.108).
The tool must be inserted into the star joint until it's upper surface lies on top of star joint.The Direction Tool (Image 3.109) will produce a click if correctly assembled.
Image 3.108: Direction Tool assembling on the needle support.
Image 3.109: Insertion clip particularity.
WARNING Check if the Direction Tool is correctly inserted into guide support. In case the anchoring
system is faulty, use a new specialized intervention kit.
3.3 PATIENT POSITIONING
Patient's positioning on the TC bed constitutes an important element for the good conduct of the intervention.
In order to perform the operation easier, an appropriate way to carry out the positioning is:
when selecting the insertion direction do not provoke an excessive Direction Tool tilt (par. 3.8.2);
do not provoke an excessive needle deflection during the insertion phase (para. 3.8.3):
The positioning does not constrain in any way the operation execution, and, in any case, is carried out so as to ensure the patient dose not get bedsores according to the common clinical practice, at the same time allowing the best intervention area exposure (Image 3.110).
Image 3.110: Possible patient positioning on the TC bed.
WARNING The detection capability of specialised intervention devices on the position sensors' behalf
could be severely compromised if the reflective sphere plan was orthogonal in respect to the plane of the two cameras (para. 1.2.2):
Place the patient so that the same position can be maintained during the entire surgical procedure: appreciable position variation during the intervention imposes new TC scans and a subsequent SIRIO system update (para. 3.8):
Patient's positioning of the must always be such as to not obstruct the passage through the CT gantry. In particular, also keep in mind the spatial volume occupied by the intervention needle during any control CT scan.
NOTE- The supine, prone or side comfortable positions can be aided by the use of operating folded
sheets, media in latex and/or foam, possibly present in the room.
3.4 APPLYING SENSORS ON THE PATIENT
3.4.1 PATIENT TOOL POSITIONING
In this phase the Patient Toolis placed on the
patient.
The tool specialized for patient monitoring constitutes the main reference system of the entire intervention procedure, being the other member of constant real time postural positions and patient's breathing monitoring .Therefore its positioning proves to be essential for the optimal execution of the intervention procedure.
For this purpose, the Patient Tool must be placed as following:
approximately in the same axial plane with the lesion being acted upon , in a lateral position (Error: Referencesource not found);
at a distance from the point of entry to ensure maximum proximity to the intervention area and minimum interference with the other instruments used later in the course of the procedure (Direction Tool and needle of intervention): a typical value of this distance is approximately 15 - 20 cm (Error: Reference source not found);
on solid areas, or in any case not very mobile, typically on the thoracic cage, so as to minimize its sensitivity to postural positions and patient's breathing.
finally, in order to minimize the thickness of the CT scan, it is desirable to position the Patient Tool so that the side with “MASMEC SIRIO RB02” is oriented approximately perpendicularly to the cranium-caudal axis.
Once the optimum position is defined, the “Patient Tool” is applied on the patient and fixed by means of common medical tape.
Image 3.111 Patient Tool
Image 3.112: Positioning of the Patient Tool in the axial plane of the lesion, in contra-lateral position.
Image 3.113: Positioning of the Patient Tool free with no interference from other intervention tools.
WARNING Patient Toolpositioning, though critical, does not restrict in any way correct intervention
execution. The SIRIO system allows , in fact, to change sensor's position at any time,
making it more suitable fort his particular case, and resume normal intervention procedure (para. 3.8.2):
When fixing of the sensor using medical tape, be careful not to conceal the spheres and not to cover the marker point.
3.4.2 BREATHING SENSOR POSITIONING
In this stage, the sensors necessary to monitor patient respiration are positioned.
The breathing monitoring system consists of two sensors connected to each other (Error:Reference source not found):
a) The X-Ray Sensorb) The Breath Sensor
THE X-Ray Sensor detects the moment when the anatomical region of interest (lesion area) is struck by CT radiation. For this purpose the X-Ray Sensor must be positioned on the CT bed in line with the patient sensor, in contact with at least the patient's chest.
The Breath Sensor, composed from a flexible strip of material, has the task of detecting the deformations of the abdomen due to the patient's breathing.
The two sensors allow respiration level recording the during the CT acquisition and subsequently indicate the level of correspondence with the current breathing. The interventionist is able to act in the moment of maximum correspondence between the reconstructed 3D model and the chest's instantaneous real conformation.
The procedure involves the insertion of two ECG clips (Error: Reference source not found) in both strip end housings that will be used to apply the same on the patient's skin. The protective film is removed from clip and strip from the patient's skin is also removed.
To locate the area and in order to respect the Breathing sensor application rules,a few simple rules should be followed:
- The strip should be applied in an area
Image 3.114: Breathing monitoring sensorsa) X-Ray Sensor; b) Breath Sensor.
Image 3.115: Breathing strip with clip.
a)
b)
bounded between the axial section containing the sternum and the axial section containing the waist (Error:Reference source not found).
- The strip should not be applied totally unfolded but slightly arched (Error:Reference source not found).
- The strip should be applied so as to connect two points of the abdomen which tend to visibly change distance during breathing.
- Avoid to strip twisting once applied.
Depending on the patient's position, the following placement is also recommend:
supine: mediolateral strip close to waist; prone: cranium-caudal direction strip on
loins;
Once the sensor has been applied, the process may be followed in the breathing window (Error: Reference source not found).
The respiratory sensor window presents:
A status icon that indicates the three states of the sensor: On-Line, X-Ray survey, Not connected.
The breathing signal line may be grey (not regular) or green (regular breathing).
The led indicators corresponding to the level acquired during CT acquisition.
The sensitivity selection bar, allows you modification of the correspondence led.
Once the Breath Sensor is applied, if the patient is breathing regularly, and the signal is green for twenty seconds (Error: Reference source notfound), then re-apply in a better position
During the CT scan, when the X-Ray Sensor is directly covered by X-rays, all leds become yellow and the icon changes to a yellow triangle (Error: Reference source not found).
The correspondence leds are activated only after
Image 3.116: Sensor application area
Image 3.117: Arc applied sensor
Image 3.118: Breathing sensor window
a) – Disconnected status
b) - On-Line status
c) - X-Ray survey
Image 3.119: Status icon
a series of images are sent to SIRIO and remain active until the session's end. From this moment onwards, you can synchronize the insertion of the needle by asking the patient to control his breath and do hold his breath for a few seconds when the LED turns green (Error: Reference source not found)
In the event of a change in the patient's posture, it is necessary to wait for the signal to re-adjust so that the leds indicate a full match.
During breathing observation, led variation may be to fast: in this case you can adjust the sensitivity selection bar (Error: Referencesource not found) to the right to allow leds to stay more or less in the green zone.
Image 3.120: Regulated breathing
Image 3.121: X-ray survey
Image 3.122: Green Led: correspondence between pulmonary CT structure and current pulmonary
structure.
Image 3.123: Red led: correspondence between pulmonary CT structure and current pulmonary structure.
3.4.3 POSTURE SENSOR POSITIONING
The posture monitoring sensors is composed of reflective markers, there position being read on an instant by instant basis by the main sensor. The application of above mentioned markers must occur after the patient's intervention position has benn fixed on the CT bed, prior to the scan. The posture is acquired using the get button of the posture tracking bar At the moment of acquire all markers are visible to the main sensor. This may is true when the number of markers in play is equal to the number of lit circular leds.
3.5 THE TOMOGRAPHIC SCAN
The tomographic scan of the anatomic region intervened upon constitutes a fundamental input datum for SIRIO system operation.
In particular, the CT scan area must be big enough to ensure total inclusion of the Patient Tool(Error: Reference source not found). This specification constitutes a indispensable constraint for the next phase of the patient registration (para. 3.7):
For total Patient Tool inclusion within the CT scan, all 4 spheres of the patient sensor must inside the scaned area, guaranteeing at the same time the minimum length of the scan area , linked to suitable positioning of the sensor (para. 3.4):
The tomographic scan, moreover, must be conducted using an acquisition step which is a distance between a slice and the next one, equal to, or at bigger than 1.5mm This parameter is essential for a suitable visibility of the 4 metal, reflective spheres (Image 3.125).
The sphere visibility also depends on the particular filtering used in the scan. For this purpose, it is necessary to use the recommended kernel convolutions , defined during the installation of the SIRIO system.
Image 3.124: Total Patient Tool inclusion in the CT scan
Image 3.125: Example of a typical tomographic scan.
WARNING Total Patient Tool inclusion essential only when the scan will be used to make for SIRIO
system update. This constraint is revoked if, instead, the new tomographic scan is only required as a TC control of implemented trajectory or of intervention needle progression.
The tomographic scan that does not meet the required characteristics, fully or in part, may cause the failure of patient's automatic registration procedure. Please refer to the patient's registration procedure (para. 3.7) for recovery procedures that must be used in this eventuality.
In order to sett-up the tomographic scan's kernel convolution, please refer to product testing ratio during system installation.
In order to minimize the thickness of the CT scan, it is desirable to position the Patient Tool so that the side with “MASMEC SIRIO RB02” is oriented approximately perpendicularly to the cranium-caudal axis.
3.6 SCAN RESULT LOADING
This phase consists in the transmission of the scan acquired from the CT to SIRIO and in the subsequent automatic organization of data related to the intervention procedure within the system database (para. 2.4):
The procedure follows the common clinical practice of sending DICOM images from the tomographic system to a remote node predisposed for standard reception (e.g. , storage and transmission of images, hospital information system).
The radiologist technician selects, therefore, the CT scan of interest and forwards the to the SIRIO remote unit.
Keep in mind that the system needs the forwarding of unique CT scan.
NOTE- SIRIO implements a DICOM listening server previously configured during system
installation(para. 1.3.1):
WARNING In case of sending multiple CT scans from the same patient or scans associated with
different patients, the system will prompt for a single correct scan.
3.7 PATIENT REGISTRATION
The patient registration stage an automatic process of SIRIO's normal operation, in conclusion completely transparent for the interventionist medic. It starts immediately after forwarding and subsequent loading of the scan within the database.
At this stage, the system activates a procedure designed to align the spatial coordinate system,
Image 3.126: Patient recording progress bar.
associated with the set of images uploaded to SIRIO, to the patient's real coordinate system.
The close correlation between the two systems allows, so to speak, to attach the virtual space to the real one, and follow in real-time the spatial variations or allow location and view of the movements of a surgical instrument, consistent with those carried out in reality.
The execution of this phase and its progress status are highlighted by the system using a proper scroll bar (Image 3.126).
At the end of the procedure, the system notifies the completion of the procedure and signals the possible error of misalignment between the two reference systems. This notification is signalled during the image-guided session(Image 3.127).
Image 3.127: Patient registration notification signal.
WARNING The patient registration procedure may not start automatically when one or more of the
following conditions are present:
a) patient sensor not fully included in forwarded scanb) registration error greater then the one set as default by the machinec) a convolution kernel reduces patient tool's steel sphere brightness d) an acquire step greater than 1.5 mme) patient respiratory failure during the CT scanf) the presence of metal objects in the series of slices forwarded
Except case (a) in which the system demands a new tomographic scan that includes all 4 spheres of the patient sensor (para. 3.5), in all other mentioned cases a manual registration procedure is automatically activated (para. 2.5.1):
3.8 IMAGE-GUIDED BROWSING SESSION
3.8.1 INTERVENTION NEEDLE REGISTRATION
This step consists of intervention needle previously sensitised length registration (para. 3.2.2): In this manner, the system is able to display in real time the location of the needle
overlaying the virtual volume of the anatomic region and assist in instrument progression toward the desired point.
To register the intervention needle it is necessary to place the tip of the needle over a marker point present in the Patient Tool, taking care to avoid any possible needle flection (Image 3.128).
A particular used marker point must be chosen so as to ensure the simultaneous visibility of Patient Tool and the Needle Tool by the position sensor: SIRIO automatically recognizes the reference being used, in any case enables accurate and precise recording
It is necessary to take the utmost care to properly insert the tip of the needle as this may constrain the automatic activation of the procedure (Image 3.129).
Under the conditions just described, the registration procedure starts automatically (Image 3.130).
Maintaining the positioning for 3 seconds will automatically complete the procedure and register the length of the intervention instrument in the system. This notification is signalled during the image-guided session(Image 3.131).
Image 3.128: Intervention needle regoistration.
Image 3.129: Marker point J particularity
Image 3.130: Automatic intervention needle registration procedure.
Image 3.131: Needle registration's notification signal.
WARNING
Check intervention needle's correct registration by pointing the instrument tip towards one or more Patient Tool spheres and verify actual correspondence with the virtual model.
Correctly place intervention instrument's tip on marker. A wrong positioning invalidates or, in worst-case scenario, prevents the automatic activation of the registration procedure.
Avoid to bend the intervention needle in the registration phase. This situation causes an incorrect measurement of the intervention instrument
Select more suitable marker point able to ensure the visibility of all 8 spheres, 4 on patient sensor and 4 on the sensing needle tool, present in the field of intervention.
Be careful not to block reflective spheres with hands. In the event automatic registration launch failure, activate the manual registration procedure
(para. 2.5.1):
3.8.2 INSERTION DIRECTION
This phase consists of entry point definition and intervention needle insertion tilt.
By using the Direction Tool previously assembled on the needle support(para. 3.2.2), a definition of maximum possible insertion trajectory may be produced based on the information provided by the system (Image3.132).
Search for the direction of insertion according to the conventional clinical method, but assisted by virtual environment made available by the SIRIO system : moving the tool with absolute freedom within the space of intervention, the needle insertion direction is identified in real time, based on axial and sagittal planes of view constantly present on the monitor.
Image 3.132: Definition of intervention trajectory maximum.
Defined in this way, the entry point of the needle, it is possible to fix the support on the patient's skin, using the device's adhesive wings or, for greater tool stability, using common medical tape (Image 3.133).
At this point a fine adjustment of the insertion direction is in order: by making angular movements with o Direction Tool rigidly connected to the support the direction of insertion is rigorously defined(Image 3.134).
At this point, it is necessary to carry out support locking in the desired position by turning star joint a ¼ of a turn clockwise.
In these conditions, you will need to do a CT scan to check the chosen direction.
Image 3.133: Fixing the needle support on the skin.
Image 3.134: Definition of insertion trajectory accuracy.
WARNING Normal use of the system requires the execution of a control tomographic scan of selected
direction. If the inspection outcome is not the one expected, repeat the direction selection procedure.
In case the TC direction control is not what the one expected, check if the patient's posture has changed significantly. In this case, perform a new tomographic scan that is to be
forwarded to SIRIO (para. 3.5): If the Direction Tool positioning is made difficult by the continuous concealment of the
Patient Tool (signalled to the monitor), move the patient sensor of a few centimetres and make a new tomographic scan to update the system.
The control scan does not necessarily have to be sent to SIRIO: if you decide to use this scan for an update of the system, it is advisable that it has the required specifications for this purpose (para. 3.5):
3.8.3 INSERTION PHASES
This the step is the intervention instrument insertion in order to perform the biopsy sampling or the thermal ablation procedure .
First of all, it is necessary to extract the Direction Tool from the needle support, without unlocking the star joint, exerting a slight pressure on clip (Image 3.135).
At this point you can introduce the needle of intervention previously sensitised (para. 3.2.2) into the support's catheter (Image 3.136).
Next step is to insert the needle through the skin with the help of SIRIO until the lesion is reached, to perform regular progression control CT scans at interventionist's discretion .
Image 3.135: Direction Tool removal clip particularity.
Image 3.136: Needle support intervention instrument introduction.
Image 3.137: Intervention needle insertion
WARNING During insertion perform regular control scans in order to monitor and verify intervention
instrument progression During Direction Tool extraction, to take the utmost care not to change in any way the
defined direction. Do not to flex the intervention needle during insertion. Be careful not to block reflective spheres with hands.
3.9 SESSION CLOSING
At the end of the intervention procedure it is necessary to exit the session tracking: this is done by pressing the Esc key on the keyboard, as notified by the monitor in the tracking panel (Image 3.138).
The system returns to the main screen. From there you can close the active session by pressing the Close button or by pressing F2 on the keyboard (Image 3.139) and prepare the system for a new intervention procedure.
Image 3.138: Tracking session exit.
Image 3.139: Closing the active session.
WARNING After using the intervention specialised kit, it must be treated and disposed of according to
normal medical practice and local and national applicable regulations.
4 SECTION 4: APPENDIX
4.1 SYSTEM MESSAGES
The system messages are generated when abnormal conditions that may or may not affect the correct functionality of the system are experiencedIn the first case the messages in question are error messages, in the second warning messages
4.1.1 ERROR MESSAGES
When a system error occurs, the user is presented with a window as shown in Image4.140, where an error code is visible. Table 4.2 summarizes the possible error codes that may occur.In all cases, the system is not able to continue its operation. The user must communicate the error code displayed to MASMEC (Technicalassistance).
Image 4.140: System error window
Table 4.2: SIRIO error codes
4.1.2 WARNING MESSAGES
4.2 TROUBLESHOOTING
This section describes the most common problems that may occur during SIRIO system operation, and the actions you apply in order to resolve these issues.All problems that are not similar to those described could limit or impair system proper functioning, and therefore should be communicated to MASMEC for their resolution (Technicalassistance).
Indication Meaning Action to be takenDuring the image-guided navigation session, an image of the patient sensor (Image 4.141) appears in the centre of the screen accompanied by a sound signal (beep).
The sensor applied on the patient is partially or completely hidden.
Make patient sensor visible to the main optical sensor by removing blocking object.
Error code Problem description000001-000001 COMM port launch error000001-000002 Optical sensor RESTEL error000001-000003 System COMM parameter setting error
000001-000004Processing unit COMM parameter setting
error000001-000005 Optical sensor initiating error000001-000006 Sensor type indication error 000001-000007 Port activity operation error000001-000008 Tracking start error000001-000009 Tracking stop errorTracking start error000001-000010 .ROM file loading error
Image 4.141: Patient sensor.During the image-guided navigation session, an image of the patient sensor (Image 4.141) appears in the centre of the screen accompanied by a sound signal (beep). The space between the patient sensor and the optical sensor is unblocked.
The patient sensor is outside the main sensor tracking range (Image 1.16).
Adjust the main optical sensor position to make the patient sensor image disappear and stop the sound signal.
During the image-guided navigation session, an image of the patient sensor (Image 4.141) appears in the centre of the screen accompanied by a sound signal (beep). The space between the patient sensor and the optical sensor is unblocked.The patient sensor is in tracking range of the position sensor.
One or more sensor mounted reflective spheres are dirty or damaged.
Clean dirty spheres or replace the patient sensor.
During the image-guided navigation session, an image of the needle sensor (Image 4.142) appears in the centre of the screen accompanied by a sound signal (beep).
Image 4.142: Needle sensor.
The needle sensor is partially or completely hidden.
Make needle sensor visible to the main optical sensor by removing blocking object.
During the image-guided navigation session, an image of the needle sensor (Image 4.142) appears in the centre of the screen accompanied by a sound signal (beep). The space between the needle sensor and the optical sensor is unblocked.The needle sensor is in tracking range of the position sensor.
The needle sensor tilt relative to the main sensor conceals one or more spheres.
Adjust the position sensor posture to make the needle sensor image disappear and stop the sound signal.
During the image-guided navigation session, an image of the needle sensor (Image 4.142) appears in the centre of the screen accompanied by a sound signal (beep). The space between the needle sensor and the optical sensor is unblocked.The needle sensor is firmly positioned within the position
One or more sensor mounted reflective spheres are dirty or damaged.
Clean dirty spheres or replace the needle sensor.
sensor's tracking range and its inclination in respect to the main sensor does not block any spheres.
4.3 CONSUMER COMPONENTS
SIRIO's consumer components represented by:
specialised intervention kit (par. 1.2.3), supplied as a sterile disposable component;
intervention needle support (par. 1.2.4), supplied as a sterile disposable (EC0434) package and produced by AprioMed AB, Virdings to 28, IF754 50 Uppsala, Sweden.The support is manufactured in three sizes, depending on the needle size with which it is to be used:
Description Colour Usable needles
14G Support Green 14G 15G
17G Support Red 17G 18G
20G Support Yellow 20G 21G
WARRANTY INFORMATION
MASMEC s.p.a. guarantees that their products will be free from material and workmanship defects for 2 years. All the products are subjected to exceptions, limitations and exclusions ass seen below..
Exceptions to present warranty:
- The battery is guaranteed up to a year in terms of performance and for 6 (six) months against manufacturing defects.
- The battery warranty is automatically invalidated, if fully charged batteries are left unused for more than 3 (three) consecutive months.
- The battery warranty is automatically invalidated, if fully discharged batteries are left unused for more than 3 (three) consecutive months.
MASMEC dose not take any responsibility in case of injury or damage caused by or associated with the use of its equipment in any way if instructions specified in this manual are not strictly abided.
CONFORMITY DECLARATION