SIRIO

User Manual
Revision 3.0

Approval
Written by

Data:
Brunetti Gioacchino, Specialized researcher
Schiraldi 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

SIRIO
User Manual
Revision 3.0

Produced by:
MASMEC S.p.A.
Via Dei Gigli, 21
Modugno 70026 - BARI
(+39) 080 5856111

TOC

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.
5

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

Red

DANGER

Orange

WARNING

Yellow

ATTENTION

None

ATTENTION

Red, orange or yellow

ELECTRICAL

White

ATTENTION

System symbols
Symbol

Meaning
6

Danger level
Indicates a situation of
imminent danger that, if not
avoided, will cause death or
serious injury.
Indicates a potential dangerous
situation that, if not avoided,
may cause death or serious
injury.
Indicates a potential dangerous
situation that, if not avoided,
may cause moderate lesions.
Used without the safety alert
symbol, indicates a potentially
hazardous situation which, if
not avoided, could result in
property damage.
Indicates
an
imminent
electrical hazard that, if not
avoided, may result in
personal injury, fire and/or
death.

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 port
Indicates 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:

ricerca@masmec.com

Telephone number:

(+39) 080 5856 261

7

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:

info@masmec.com

Telephone number:
Fax:

(+39) 080 5856 111

(+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.

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 preintervention 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.

Tomograph

Infrared tracking
sensor
and field devices

Processing and
display unit

Specialised
intervention kit

Image 1.1: SIRIO system overview.

10

1.2

SYSTEM COMPONENTS

PROCESSING AND DISPLAY UNIT

b
a

c
b
d
c

f
a

e
d

a.
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

Image 1.2: Processing and display unit front and side view.

e
d

g
e.

Image 1.3: Unit details.

11

Powered carriage for LCD

Power supply connection

f.

Data tracking and

transmission system connection

g.

System power-on interface

and uninterruptible power supply
monitoring

POSITIONING SENSOR
1
1. Positioning sensor

2. USB converter
Image 1.4: Positioning sensor.

3. Power supply adaptor

SPECIALISED
INTERVENTION KIT

II

III

I.

Patient Tool

II.

Needle Tool

III.

Image 1.5: Specialised intervention kit

Direction Tool

NEEDLE SUPPORT

Sterile intervention needle support (from

14G, 17G, and 20G)

Image 1.6: Intervention needle support.

12

BREATHING MONITORING SENSORS

II

I.
II.

Image 1.7: Breathing monitoring sensors.

Breathing Sensor
X-Ray Sensor

POSTURE MONITORING MARKER

Group of 12 reflective markers

Image 1.8: Adhesive posture monitoring markers

13

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.
B.
C.
D.
E.
F.

Screen independent positioning

hight adjustment for best ergonomic
positioning
acquisition and processing unit
compartment security and flexibility
automatic locking drawer
keyboard shelf with backward tilt
manoeuvrability that does not
require effort

C
D

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.

F
Image 1.9: Powered carriage functional
characteristics.

Carriage technical characteristics are presented

below (Image 1 .10):

14

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 mm
4. Front handle
5. Height adjustment lock
6. The "Ready On" start-up button returns the computer to full functionality mode from standby mode.
7. USB hub
8. The keyboard shelf slides out, and tilts, allowing mouse use to the left or right with proper
care.
9. Light keyboard under the front handle
10. Excess cable and power supply compartment.
11. Utensil holder compartment and rear handle
12. Front swivel and lockable wheels
13. Automatic locking drawer
14. Carriage base integrated power supply system.

LCD touch screen for medical applications

15

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

Image 1.12: Position sensor operating principle

16

processing data through the USB

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).

Sensor

IR transmitter
Image 1.13: Positioning sensor.

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.

Laser outlet
LED indicators

Status LED
:
Continuously glows with a green light
when the communication connection
between the position sensor and
processing unit is available.

Laser activation
Image 1.14: LED and laser outlet proprieties.

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

17

converter to the position sensor, it's

function being data transmission and
sensor power supply;
-

Power supply
connector

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.

Position sensor's built-in

cable

USB connector
Image 1.15: USB converter

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.

Image 1.16: Position sensor's characteristic

measurement volume

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 angle
This parameter specifies the maximum
acceptable angle between a tool and
18

each of the two radiation detecting

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).

Maximum angle

2. Sphere visibility
The 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.

1.2.3

Normal to the
plane

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
radiation capable of damaging the human eye.
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.

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
19

- 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.
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 Tool
This is an instrument provided with sensors able
to track the patient's postural position and
breathing.
Words of reference

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):

Marker
point

The expression MASMEC SIRIO

RB02 is used as a reference to patient
sensor implementation stage (par. 3.4):
Image 1.18: Patient Tool and its fundamental
characteristics

The Needle Tool

This 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 Tool

20

This 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).

Insertion
section

Image 1.19: The Patient Tool and its fundamental

characteristics

Insertion
section

Image 1.20: The Direction Tool and its fundamental

characteristics

1.2.4

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.

INTERVENTION NEEDLE SUPPORT

21

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.

Image 1.21: intervention needle support.

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).

Hemispherical
arcs

Access
catheter
Image 1.22: Hemispherical adjustment arches and
needle access catheter.

The system's star shape locking coupling (Image

1 .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.

Image 1.23: Star shape locking coupling detail.

The tool produced

visible indication
Direction Tool, at
tomographic scan
(Image 1 .24).

by the support provides a

of the path set by the
the time of the control
of undertaken trajectory

Image 1.24: Needle support tool.

22

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 1.25: Multiple samples authorized by SIRIO.

The support is available in different

configurations, allowing different needle size
mounting according to the chart below (Image
1 .26):
Description
14G Support
17G Support
20G Support

Colour
Green
Red
Yellow

Usable needles
14G 15G
17G 18G
20G 21G
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
23

not take into account the changes induced by

patient respiration, which may produce
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

24

1.3
1.3.1

SYSTEM TENDENCY
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 preassembled 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).

Guidance
references

Image 1.29: Position sensor's connection

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 1.30: Monitor connection panel.

AC IN socket

Power
cord
Safety
support

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 network
In 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
Port
TCP/IP

SIRIO
104
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.

1.3.2

Image 1.33: Ethernet data connection particular

access point.

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(Image 1
.34).

Image 1.34: Unit location in frontal position.

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 1.35: Processing and display unit ergonomic
positioning

Position sensor positioning

The proper position sensor placement is

essential for the efficient use of the SIRIO
system.

Positioning
sensor

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
Image 1.36: Optimal position sensor positioning

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 sensor

This configuration maintains the work space to
the fullest extent, guaranteeing a minimum

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 sensor

The mobile configuration allows position sensor
maximum manoeuvrability, resulting in,
however, a minimal obstacle within the
workspace.

Image 1.37: Celling positioning of the position sensor

Image 1.38: Celling positioning of the position sensor

particularities

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
lightly pressing the pedal, the telescopic tubular
Wheel with
brake

Wheel Foot
with
Right
330
control
/ left
mmrotation
brake 180hight
Pivot 360 +75
-5 Inclination

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 sensor
Position 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.

Switch on
LED

Switch on/off
button
Image 1.42: System switch on

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.

1.4

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.
SYSTEM FUNCTIONALITY

1.4.1 GENERALITIES
The main features of the SIRIO medical device are:

DICOM standard management

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 twodimensional 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
Dimensions
Weight
Power supply
Certification

Value
See Image 1 .43.
approximately 65kg
230 VAC, 50 Hz, single phase
66 Ah power supply system with two (2) 33
Ah batteries, 12V DC.
EN e IEC 60601-1
EN 55011 A Class (CISPR 11)
EN 55024

Image 1.43: LCD powered carriage overall dimensions.

LCD monitor

Characteristic
Dimensions
Weight
Power consumption
Power supply
Input signal

Value
506 x 444 x 119 mm (L x A x P) (Image 1 .
44)
approximately 9.8 kg
Maximum: approximately 100 W
Standard: approximately 92 W
From 100 to 240 V AC 10 %, 50/60 Hz,
single phase (multiple socket power supply
inside the carriage).
VGA connector

Certification

EN IEC 60601-1.

Image 1.44: Overall monitor dimensions.

Acquisition and processing unit

Characteristic
Dimensions
Weight
Power supply
Certification

Value
378 x 49 x 309 mm (L x A x P)
approximately 4 kg
230 VAC, 50 Hz, single phase
A.C. adaptor 150 W
Compliant with safety and reference
electromagnetic compatibility standards.

The position sensor

Sensor

Characteristic
Dimensions
Weight
Input voltage
Power consumption
Laser class
Laser wavelength
Maximum power
Standard laser
Certification

USB converter

Value
613 x 104 x 84 mm
1.9 kg
26 VDC
13.5 W
2
635 nm
1mW
- ANSI Z136.1
- IEC 60825-1
- FDA/CDRH 21 CFR 1040.10 and 1040.11
EN 60601-1
EN 60601-1-2
EN IEC 60825-1
1999/5/EC R&TTE Directive

Characteristic
Dimensions
Weight
Interface
Input voltage
Output voltage
Power consumption

Value
88 x 57 x 39 mm
0.35 kg
USB
24 VDC
26 VDC
< 2W

Power supply adaptor

Characteristic
Dimensions
Weight
Input voltage
Output voltage
Power consumption

Value
125 x 62 x 32 mm
0.37 kg
100 VAC to 240 VAC, 50/60 Hz26 VDC
24 VDC @ 2.1 A
50 W (max.) (24 W typical)

System precision
SIRIO'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 E pS
satisfies the following inequality:
E pS 2mm 100mm
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 (Image 1 .
45).

Image 1.45: Processing and display unit

transport

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:

Image 1.46: Step 1: turn off the monitor.

1. turning off the LCD 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 (Image
1 .49).

Image 1.47: Step 2: connect

the power cord.

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 1.48: 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
Atmospheric pressure p
Relative humidity h
Temperature T

Value range
50 kPa p 106 kPa
10% h 90%
-10C 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 maintenance

There 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 wheels
Check 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 cables

Check 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 load

Make
sure
that
specified
maximum loads are not exceeded

Each day

Any user

System SLA power

supply battery

Replace lead-acid batteries

When the system indicates it, or

when the remained maximum
battery life is half the original

MASMEC

Each month

Technical personnel

Each month

Technical personnel

Each weak

Any user

When you have reason to believe

that the sensor has suffered
mechanical and environmental
shocks.

MASMEC

Power supply module

Battery cable
Spiral cable

Check air intake slot for dust and

clean, if necessary, with a vacuum
cleaner.
Check if worn or crushed, if the
sheath is cracked or damaged in
any other way
Check if worn, overstretched or
damaged. Move the hook holding
it, to avoid cable drag on the floor

Positioning sensor

Check the
calibration

position

sensor's

Processing unit

Check 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 maintenance

Position 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.
WORKING FOLDER PANEL
MAIN TOOLBAR

TOOL PANEL

CAPTION BAR

TOOL BUTTON

SESSION EXPLORER

POSTURE TRACKING BAR

BREATHING TRACKING BAR

VISUALIZATION PANEL
SESSION TREE

IMAGE EXPLORER

STATUS BAR

Image 2.51: SIRIO's main frame.

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

NOTE
Some 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.
NOTE
The 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 subpanel, each relating to a phase of the
intervention session. Each sub-panel, in turn, is
composed of one or more function keys.

Image 2.55: The Session panel.

 Patient and Session

This sub-panel (Image 2 .56) contains browser
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 Series
This 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 Image 2 .
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.

WARNING
The 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.
Register
The 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.

NOTE
Patient registration is a procedure performed automatically by the system as a standard operation
during an intervention procedure (para. 3.7):

WARNING
Patient 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 Session
The 3D Session (Image 2 .69) sub-panel
contains SIRIO's most important feature. By
selecting the tracking session key, the threedimensional 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 registered
the 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 panel
This 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 panel
This 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 panel
This 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 (Image 2 .
73).
Finally we'll emphasize button features and their
meaning and other indicators located on the bar.

Image 2.72: Needle not acquired.

Image 2.73: Needle acquisition not updated

- Breathing tracking
The meaning of the indicators of this window
and its features are dealt with in paragraph
3.4.2.
- Posture tracking
The meaning of the indicators of this window
and its features are dealt with in paragraph 2.8.

Image 2.74: Only two-dimensional

panel display

- Trajectory
By 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):
- Views
By 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).
- Windowing
By 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 2.75: Only 3D panel display

- Manual needle registration

By 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;

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
Image 2.79: The View panel.

The IDL Output panel is only activated by

superior entry to user level.

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

Image 2.80: Image tools panel

Image 2.81: Measurement of the distance between two

points.

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 2.82: 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 session
described in detail below.
Tracking session
The tracking mode was already described in the
sub-panel 3D session of the panel session (para.
2.5.1):
Playing session
In 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
stop

Image 2.86: Player connection panel.

and a progress giving the possibility to jump to

any sequence point.
Viewing session
In 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.

NOTE
The 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;
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 2.92: The options panel.

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.

Image 2.96: The TAG sub-panel

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

(a) disabled

(b) enabled and not tracking

(c) enabled and tracking

Image 2.101: Main optical sensor

status indicators.

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) 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.

3.2.2

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.

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.

Image 3.107: Intervention needle sensing.

2.

Direction Tool mounting on the needle

support
Assemble the tool on the support, by
introducing the insertion section into the star
shaped joint (Image 3 .108).

Image 3.108: Direction Tool assembling on the needle

support.

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 3.109: 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: Reference
source 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);

Image 3.111 Patient Tool

Image 3.112: Positioning of the Patient Tool in the

axial plane of the lesion, in contra-lateral position.

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 3.113: 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,

3.4.2

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.
BREATHING SENSOR POSITIONING

In this stage, the sensors necessary to monitor

patient respiration are positioned.

b)

The breathing monitoring system consists of

two sensors connected to each other (Error:
Reference source not found):
a) The X-Ray Sensor
b) 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 XRay Sensor must be positioned on the CT bed
in line with the patient sensor, in contact with at
least the patient's chest.

a)

Image 3.114: Breathing monitoring sensors

a) X-Ray Sensor; b) Breath Sensor.

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 3.115: Breathing strip with clip.

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.

Image 3.116: Sensor application area

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;

Image 3.117: Arc applied sensor

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 Image 3.118: Breathing sensor window
breathing).

The led indicators corresponding to the

level acquired during CT acquisition.

a) Disconnected status

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 not
found), 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).

b) - On-Line status

c) - X-Ray survey
Image 3.119: Status icon

The correspondence leds are activated only after

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)

Image 3.120: Regulated breathing

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: Reference
source not found) to the right to allow leds to
stay more or less in the green zone.

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).

Image 3.124: Total Patient Tool inclusion in the CT

scan

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 3.125: 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

3.6

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.

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

Image 3.126: Patient recording progress bar.

designed to align the spatial coordinate system,

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).

Image 3.127: Patient registration notification signal.

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).

WARNING
The patient registration procedure may not start automatically when one or more of the
following conditions are present:
a)
b)
c)
d)
e)
f)

patient sensor not fully included in forwarded scan

registration error greater then the one set as default by the machine
a convolution kernel reduces patient tool's steel sphere brightness
an acquire step greater than 1.5 mm
patient respiratory failure during the CT scan
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).

Image 3.128: Intervention needle regoistration.

Under the conditions just described, the

registration procedure starts automatically
(Image 3 .130).
Image 3.129: Marker point J particularity

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 3.130: Automatic intervention needle

registration procedure.

Image 3.131: Needle registration's notification signal.

WARNING

3.8.2

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):

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 (Image 3 .
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).

Image 3.133: Fixing the needle support on the skin.

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 of a turn clockwise.
In these conditions, you will need to do a CT
scan to check the chosen direction.

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

3.8.3

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):

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).

Image 3.135: Direction Tool removal clip particularity.

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 3.136: 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 experienced
In 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 Image 4 .
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
(Technical
assistance).

Image 4.140: System error window

Table 4.2: SIRIO error codes

Error code
000001-000001
000001-000002
000001-000003
000001-000004
000001-000005
000001-000006
000001-000007
000001-000008
000001-000009
000001-000010

4.1.2

Problem description
COMM port launch error
Optical sensor RESTEL error
System COMM parameter setting error
Processing unit COMM parameter setting
error
Optical sensor initiating error
Sensor type indication error
Port activity operation error
Tracking start error
Tracking stop errorTracking start error
.ROM file loading error

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 (Technical
assistance).
Indication

Meaning

Action to be taken

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 sensor applied on the patient is

partially or completely hidden.

Make patient sensor visible to the

main optical sensor by removing
blocking object.

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).

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

One or more sensor mounted

reflective spheres are dirty or
damaged.

Clean dirty spheres or replace the

needle sensor.

Image 4.142: Needle sensor.

positioned within the position

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
14G Support
17G Support

Colour
Green
Red

Usable needles
14G 15G
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