Sirona Galileos User Manual

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General information	Sirona Dental Systems GmbH
	Operating Instructions GALILEOS

General information

Dear Customer,	Thank you for purchasing your GALILEOS X-ray device.
	The GALILEOS system consists of an X-ray device that
	uses a cone beam with a rotational sequence to provide
	two dimensional images and three dimensional volume
	reconstructions of the head area, including both the ENT
	and the dentomaxillofacial areas, for use in planning and
	diagnostic support.
	The system also includes a package of PC software
	modules (GALAXIS, REKO Software) which extend the
	capabilities of SIDEXIS to include the handling of 3D
	data. This includes the 3D reconstruction, storage,
	retrieval, viewing and processing of 3D image data.
	The technical documentation supplied is also part of
	the product. Keep these documents handy at all times.
	To safeguard your warranty claims, please complete the
	attached “Installation Report/Warranty Passport”
	together with the service engineer immediately after the
	installation of your unit.
	Please familiarize yourself with the unit by reading
	through these Operating Instructions before taking
	any X-rays of patients. Always observe the valid radia-
	tion protection regulations and warnings.
	These operating instructions presuppose that you are
	familiar with the use of the SIDEXIS software.
	SIRONA requires regular constancy tests to ensure the
	image quality.
	Your GALILEOS Team
Maintenance	In the interest of the safety and health of patients, users
	and other persons, inspection and preventive mainte-
	nance must be performed at scheduled intervals to
	ensure the operational reliability and functional safety of
	your product (IEC 60601-1 / DIN EN 60601-1 etc.).
	The system owner must ensure that all inspections and
	maintenance events take place.
	If the system owner fails to fulfill the obligation to have
	inspections and maintenance work performed or ignores
	error messages, Sirona Dental Systems GmbH and its
	authorized dealers cannot assume any liability for result-
	ing damage.

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Sirona Dental Systems GmbH	Contents
Operating Instructions GALILEOS

Contents

1	Warning and safety information ................................................................................		5
	1.1	General safety information................................................................................................................	5
	1.2	ESD protective measures .................................................................................................................	9
	1.3	About the physics of electrostatic charges .......................................................................................	10

2	Technical description .................................................................................................		11
3	Controls and functional elements .............................................................................		15
	3.1	Operating and Display Elements ......................................................................................................	15
	3.2	General touchscreen functions on Easypad .....................................................................................	17
	3.3	High contrast option..........................................................................................................................	23

4	Accessories .................................................................................................................		25
	4.1	Bite blocks, supports and fasteners..................................................................................................	25
	4.2	Hygienic protective sleeves ..............................................................................................................	26
	4.3	Test phantom for acceptance/constancy test ...................................................................................	27

5	Programs......................................................................................................................		28
	5.1	VO1: Volume 1 (High-resolution program) .......................................................................................	28
	5.2	VO1 HC: Volume 1 (High contrast option (HC)) ...............................................................................	29
	5.3	VO2: Volume 2 (standard program)..................................................................................................	30
	5.4	VO2 HC: Volume 2 (High contrast option (HC)) ...............................................................................	31

6	Operation .....................................................................................................................		32
	6.1	Preparing the exposure ....................................................................................................................	32
	6.2	Selecting exposure parameters ........................................................................................................	37
	6.3	Positioning the patient ......................................................................................................................	38
	6.4	Releasing the exposure ....................................................................................................................	45
	6.5	Remote control .................................................................................................................................	48

7	List of messages .........................................................................................................		49
	7.1	List of help messages .......................................................................................................................	49
	7.2	Error message structure ...................................................................................................................	50
	7.3	Error message E1 10 07...................................................................................................................	52

8	Care of outer surfaces ................................................................................................		53
9	Inspection and maintenance ......................................................................................		54
	9.1	Annual check performed by the system owner or other authorized persons....................................	54
	9.2	Maintenance by the service engineer ...............................................................................................	54
	9.3	Image quality check ..........................................................................................................................	54

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Contents	Sirona Dental Systems GmbH
	Operating Instructions GALILEOS

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Sirona Dental Systems GmbH	1 Warning and safety information
Operating Instructions GALILEOS	1.1 General safety information

1 Warning and safety information

1.1	General safety information
Identification of warning and safety information		To prevent any personal injury or material damage,
		please observe the warning and safety information pro-
		vided in the present operating instructions. All such infor-
		mation is highlighted by the signal words NOTE,
		CAUTION or WARNING.
Symbols used		Observe accompanying documents
		(on rating plate)
Intended use		The GALILEOS system consists of an X-ray device that
		uses a cone beam with a rotational sequence to provide
		two dimensional images and three dimensional volume
		reconstructions of the head area, including both the ENT
		and the dentomaxillofacial areas, for use in planning and
		diagnostic support.
		The system also includes a package of PC software
		modules (GALAXIS, REKO Software) which extend the
		capabilities of SIDEXIS to include the handling of 3D
		data. This includes the 3D reconstruction, storage,
		retrieval, viewing and processing of 3D image data.
		This system must not be used in areas subject to explo-
		sion hazards.
		With room temperatures > 35 °C (> 95 °F) Sirona recom-
		mends the use of an air conditioning system.
		Recommended operating temperature: < 35 °C (< 95 °F)
		Caution:
		Federal Law (USA) restricts sale of this device to or on
		the order of a physician, dentist or licensed practitioner.
Maintenance and repair		As manufacturers of medical electrical equipment we
		can assume responsibility for the safety-related features
		of the equipment only if maintenance and repair are
		carried out only by ourselves or agencies expressly
		authorized by us, and if components affecting safe oper-
		ation of the system are replaced with original spare
		parts upon failure.
		We suggest that you request a certificate showing the
		nature and extent of the work performed from those who
		carry out such work; it must contain any changes in rated
		parameters or working ranges (if applicable), as well as
		the date, the name of the company and a signature.
Modifications to the system		Modifications to this system which might affect the safety
		of the system owner, patients or other persons are pro-
		hibited by law!

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1 Warning and safety information	Sirona Dental Systems GmbH
1.1 General safety information	Operating Instructions GALILEOS
	For reasons of product safety, this product may be
	operated only with original Sirona accessories or
	third-party accessories expressly approved by Sirona.
	The user assumes the risk of using non-approved
	accessories.
Combination with other equipment	Permissible combinations are specified in the Declara-
	tion of Conformity and confirmed by the system integra-
	tor (service engineer).
Ventilation slots	Under no circumstances may the ventilation slots on the
	unit be covered, since otherwise the air circulation will be
	obstructed.
	Do not spray disinfectants or other similar products into
	the ventilation slots.
X-raying of patients	X-rays of patients must be taken only when the system
	works without errors.
	The system may only be operated by skilled or prop-
	erly trained personnel.
	The movements of the unit must not be obstructed by
	physical constitution nor clothing, dressings, wheel-
	chairs or hospital beds!
	Do not leave the patient unattended in the unit.
Electromagnetic compatibility (EMC)	The GALILEOS X-ray unit complies with the require-
	ments of IEC 60601-1-2: 2001.
	Medical electrical equipment is subject to special pre-
	cautionary measures regarding EMC. It must be
	installed and operated as specified in the document
	“Installation Requirements”.
	If high-voltage systems, radio link systems or MRI sys-
	tems are located within 5 m of the unit, please observe
	the guidelines the installation requirements.
	Portable and mobile RF communications equipment
	may interfere with medical electrical equipment. There-
	fore, the use of mobile wireless phones in practice or
	hospital environments must be prohibited.
	Please also observe the ESD protective measures in
	Chapter 1.2.
Precautionary measures when switching on the unit	Following extreme temperature fluctuations, condensa-
	tion may occur; therefore please do not switch on the
	system until it has reached normal room temperature
	(see chapter “Technical Description”).
	No patient may be positioned in the unit during
	power-on.
	In case of an error that requires switching the unit off and
	back on again, the patient must be removed from the
	unit, at the latest before switching the unit on again!

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Sirona Dental Systems GmbH	1 Warning and safety information
Operating Instructions GALILEOS	1.1 General safety information
Emergency stop (not included in the scope of supply)	If any parts of the unit touch the patient during the rotary
	movement, let go of the exposure release button
	(X-Ray) immediately or stop the unit at once by actuating
	the unit main switch or an Emergency Stop switch!

Disturbance of electronic devices worn on the patient’s body

Radiation protection

Hygiene information

Structural alterations

Dismantling and reassembly

Disposal

To prevent the malfunctioning of electronic devices and data storage devices, e.g. radio-controlled watches, telephone cards, etc., these objects must be removed prior to X-raying.

The valid radiation protection regulations must be observed.

The operator should move as far away from the X-ray tube assembly as allowed by the coiled cable of the exposure release button.

The statutory radiation protection equipment must be used.

With the exception of the patient, no other persons without radiation protection are allowed to stay in the room. In exceptional cases, a third person may provide assistance, but not the practice staff. During the whole exposure, visual contact with the patient and the unit must be maintained.

In case of malfunctions, cancel the exposure immediately by letting go of the exposure release button.

The bite block should be resterilized for each new patient to prevent any possible transmission of infective agents which might under certain circumstances cause serious illnesses.

Also be sure to use hygienic protective sleeves.

Suitable hygienic measures must be taken to prevent cross contamination among patients, users and other persons.

If structural alterations are made in the immediate vicinity of the unit, a technical check must be made by the service engineer.

When dismantling and reassembling the system, proceed according to the installation instructions for new installation in order to guarantee its proper functioning and stability.

The X-ray unit must be recalibrated whenever structural alterations in the area surrounding the X-ray room or new installations have been performed.

It generally applies that any disposal of this product must comply with the relevant national regulations. Please observe the regulations applicable in your country.

Within the European Economic Community, Council Directive 2002/96/EU (WEEE) requires environmentally sound recycling/disposal of electrical and electronic devices.

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1 Warning and safety information	Sirona Dental Systems GmbH
1.1 General safety information	Operating Instructions GALILEOS

Laser light localizer used

Your product is marked with the adjacent symbol. Disposal of your product with domestic refuse is not compatible with the objectives of environmentally sound recycling/disposal.

The black bar underneath the "garbage can" symbol means that it was put into circulation after Aug. 13, 2005. (see EN 50419:2005)

Please note that this product is subject to Council Directive 2002/96/EU (WEEE) and the applicable national law of your country and must be recycled or disposed of in an environmentally sound manner.

The X-ray tube assembly of this product contains a tube with a potential implosion hazard, a small amount of beryllium, a lead lining and mineral oil.

Please contact your dealer if final disposal of your product is required.

The system incorporates Class 1 laser products.

The light localizer is used for correct patient positioning. It must not be used for any other purposes.

A minimum distance of 100mm (4“) between the eye and the laser is required. Do not stare into the beam. Its safe operation is described in chapter 6.3 "Positioning the patient".

The light localizer may be switched on only if it is functioning properly and faultlessly. Repair work must be carried out by authorized staff only.

Do not look directly into the beam.

CAUTION

Do not use any other lasers and avoid changing any settings or processes not described in these instructions, as such actions could result in hazardous radiation exposure.

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Sirona Dental Systems GmbH	1 Warning and safety information
Operating Instructions GALILEOS	1.2 ESD protective measures

1.2 ESD protective measures

ESD stands for ElectroStatic Discharge.

CAUTION

Connector pins or sockets bearing ESD warning labels must not be touched or interconnected without ESD protective measures.

ESD protective measures include:

• Procedures for preventing electrostatic charge build-up (e.g. air conditioning, air moistening, conductive floor coverings and non-synthetic clothing)

• Discharging the electrostatic charges of your own body on the frame of the unit, the protective ground wire or large metallic objects

• Connecting yourself to ground using a wrist band.

We therefore recommend that all persons working with this system be instructed on the significance of this warning label. Furthermore, they also should receive training in the physics of electrostatic discharges which can occur in the practice and the destruction of electronic components which may result if such components are touched by electrostatically charged USERS.

The content of this training is explained in Chapter 1.3.

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1 Warning and safety information	Sirona Dental Systems GmbH
1.3 About the physics of electrostatic charges	Operating Instructions GALILEOS

1.3 About the physics of electrostatic charges

1 nanosecond = 1/1,000,000,000 second =

1 billionth of a second

ESD stands for ElectroStatic Discharge. Electrostatic discharge must be preceded by electrostatic charging.

Static electric charges generally build up whenever two bodies are rubbed against each other, e.g. when walking (shoe soles against the floor) or driving a vehicle (tires against the street pavement). The amount of charge depends on several factors:

Thus the charge is higher in an environment with low air humidity than in one with high air humidity; it is also higher with synthetic materials than with natural materials (clothing, floor coverings).

The following rule of thumb can be applied to assess the transient voltages resulting from an electrostatic discharge.

An electrostatic discharge is:

•perceptible at 3,000 V or higher

•audible at 5,000 V or higher (cracking, crackling)

•visible at 10,000 V or higher (arc-over)

The transient currents resulting from these discharges have a magnitude of 10 amperes. They are not hazardous for humans because they last for only several nanoseconds.

Voltage differentials exceeding 30,000 volts per centimeter may lead to a charge transfer (electrostatic discharge, lightning, arc-over).

Integrated circuits (logical circuits and microprocessors) are used in order to implement a wide variety of functions in dental/X-ray/CEREC systems. The circuits must be miniaturized to a very high degree in order to include as many functions as possible on these chips. This leads to structure thicknesses as low as a few ten thousandths of a millimeter.

It is obvious that integrated circuits which are connected to plugs leading outside of the unit via cables are sensitive to electrostatic discharge. Even voltages which are imperceptible to the user can cause breakdown of the structures, thus leading to a discharge current which melts the chip in the affected areas. Damage to individual integrated circuits may cause malfunction or failure of the system.

To prevent this from happening, the ESD warning label next to the plug warns of this hazard.

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Sirona Dental Systems GmbH	2 Technical description
Operating Instructions GALILEOS

2 Technical description

Chassis:	Model designation	GALILEOS
	Nominal voltage:	200 – 240V
	Permissible deviation:	±10%
	Permissible drop under load:	10%
	Rated current:	6A
	Nominal power output X-ray tube:	0.6kW at 85kV/7mA
	Current time product X-ray tube:	42mAs
	Nominal frequency:	50/60 Hz
	Internal line impedance:	max. 0.8Ohm
	Main building fuse:	25A slow-blow (16A for standalone connection)
	Power consumption:	0.9kVA
X-ray tube assembly:	Focal spot size acc. to IEC 60336,
	measured in the central X-ray beam:	0.5
	kV:	85 kV
	mA:	5/7 mA
	Pulsed mode:	10 ms – 30 ms
	Total filtration of X-ray tube assembly	> 2.5 Al/90 IEC 522
	Cone-beam angle:	collimated to approx. 24°
Detector:	Type: Image intensifier (I.I.), Thales
	Active input window size:	215 mm (8 1/2“) diameter
	Camera:	Pixels: 10002
		FPS: 15 – 30
		Dynamics: 12 bits, (4096 brightness values), 60 dB
Geometry:	Source-I.I. converter coating distance	510 mm (20 1/16“)
	(central X-ray beam)
	Source-isocenter distance	333 mm (13 1/8“)
	(central X-ray beam)
	Source-skin distance	approx. 220 mm (8 5/8“)
	(minimum distance)
Scanning operation:	Orbital angle	204°
	Scan time	approx. 14 s
	Number of single exposures	200

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2 Technical description	Sirona Dental Systems GmbH
	Operating Instructions GALILEOS

Reconstruction: Filtered backprojection

Marking of focal spot:

	Automatic exposure blocking (see	The duration of automatic exposure blocking (cool-
	page 46):	ing period) depends on the set kV/mA level and
		the actual exposure time. Depending on the tube
		load, a pause duration of 8 s to 300 s is automati-
		cally set by the system.
	Class I equipment	Type B equipment
	Degree of protection against electric
	shock:
	Degree of protection against ingress of	Ordinary equipment
	water:	(without protection against ingress of water)
	Year of manufacture	(on the rating plate)
	Mode of operation:	Continuous operation
	Long-term power output:	100W
	Anode material:	Tungsten
	Exposure parameters for determining	7mA/85 kV
	leakage radiation:
	Long time current for leackage radia-	0,14 mA
	tion measurement:
	Transport and storage temperature:
	Basic unit	-40°C – +70°C (-40°F – 158°F)
	Detector	-30°C – +55 °C (-22 °F – 131 °F)
	Air humidity:	10% – 95% without condensation
	Admissible operating temperature:	from +10 °C to +35 °C (50 °F – 95 °F)
X-ray tube:	DF-151R – from Toshiba

Minimum requirements for reconstruction PC (included in the scope of supply):

Processor:	2x 3.0 GHz, alternatively dual-core
RAM:	2 GB RAM
Hard disks:	> 200 GB
Operating system:	Windows XP Professional Service Pack 2 or newer
External drive:	1x DVD writer, dual-layer
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Sirona Dental Systems GmbH

Operating Instructions GALILEOS

Minimum requirements for SIDEXIS visualization PC (included in the scope of supply):

Network:

Network:

Communication interface:

2 Technical description

	See SIDEXIS XG Operator’s Manual.	bеЦдблЬ
	100 MB Ethernet, 1 Gbit Ethernet recommended
	RJ45 for LAN cable

The GALILEOS X-ray unit complies with IEC 60601-2-28/1993

The GALILEOS X-ray unit complies with IEC 60601-1-3/1994

The GALILEOS X-ray unit complies with IEC 60601-2-7/1998

The GALILEOS X-ray unit complies with AS / NZS 3200.1.0
Original language:	German

This product bears the CE mark in accordance with the provisions of the Council Directive 93/42/EEC of

June 14, 1993 concerning medical devices.

0123

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2 Technical description	Sirona Dental Systems GmbH
	Operating Instructions GALILEOS

Cooling curve of tube housing

	HUx104		1 HU = 1.35 Joule
130
120
110
100
90
80
70
60
50
40
30
20
10																	t
0	60		120	180		240		300		360	420	480	540	600	660	720	min
	HUx103			1 HU = 1.35 Joule									Cooling curve of X-ray tube
35
30
25
20
15
10
5												t
0	1	2	3	4	5	6		7	8	9	10	min
HUx104													Heating curve of tube housing
			1 HU = 1.35 Joule
130
								t
0	1	2	3	4		5	6	h

Central X-ray beam/anode angle

Central X-ray beam

10°

16°

Anode angle

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Sirona Dental Systems GmbH	3 Controls and functional elements
Operating Instructions GALILEOS	3.1 Operating and Display Elements

3 Controls and functional elements

3.1 Operating and Display Elements

1				2	3	4
5	6	7	8	9	10	11
H
E				G
				F
B
I						I
C	D	A
		J
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on the GALILEOS

1Main switch

2Forehead support

(contact upholstery detachable and sterilizable)

3Head fastening strap

4Bite block (sterilizable)

5Release button

i NOTE

If the system is installed with a remote control, the release button is attached to the remote control.

6Easypad (swivelable control panel)

7Light localizer, central light beam for face center

8Swivel arm for patient immobilization

9Handles for patient

10Rotary knob for bite-block locking device

11Rotary knob for swivel-arm lock and forehead support setting

on the head fixation device

A	Forehead rest (in two versions)
B	Forehead rest adjustment
C	Headband adjustment
D	Pushbutton for resetting forehead rest
E	Lock for vertical adjustment
F	Scale for vertical adjustment
	(adjustment range +/- 10 mm)
G	Scale for horizontal adjustment
	(adjustment range +16 mm /-20 mm)
H	Locking button for horizontal adjustment and
	unlocking head fixation device for removal
I	Locking buttons for headband
J	Ear plugs

15

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3 Controls and functional elements

3.1 Operating and Display Elements

12		13 14			15				16

TR

17 18

19

16

Sirona Dental Systems GmbH

Operating Instructions GALILEOS

Controls and displays on the Easypad with touchscreen

12Light localizer ON/OFF

13“Unit up” arrow key

14“Unit down” arrow key

15Optical radiation indicator

16“Unit ON” LED

17“T“ key for test cycle without radiation

18“R“ key for unit return

19Touchscreen – touch-sensitive screen

CAUTION

Never touch the touchscreen with sharp or pointed objects (ball-point pens, pencils, etc.)!

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Sirona Dental Systems GmbH	3 Controls and functional elements
Operating Instructions GALILEOS	3.2 General touchscreen functions on Easypad

3.2 General touchscreen functions on Easypad

1

2

11

3 4

5

6

7

10

8

9

Touchscreen = touch-sensitive screen, i.e. different functions can be triggered by touching the screen surface.

Color codes:

orange – selected

white – presettings

light blue – selectable

gray and white – auxiliary symbols

Touchscreen symbols

1Display of height setting value

2Display of program VO1, VO1 HC (with high contrast option) or VO2, VO2 HC (with high contrast option).

The grid contrast shows the corresponding contrast option.

Normal contrast (without high contrast option):

High contrast (high contrast option (HC)):

3Submenu column (options)

4Blue arrows: Select submenu, close menu

5Red symbol for light localizer ON (is displayed as long as the laser light of the light localizer is switched on)

6 Patient symbol keys for selecting preset exposure parameters

7 Comment line for help and error messages

8 Display/setting of exposure parameters (kV/mAs)

9 When you touch the ? symbol, the help or info screen is displayed

10 Display/settings of the high contrast option

11 Program selection keys –/+

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