Sirona Orthophos 3 DS User Manual

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	Sirona Dental Systems GmbH
Dear Customer	Thank you for purchasing your new ORTHOPHOS 3 DS
	X-ray unit for panorama planigraphy.
	For this unit we have provided you with a set of techni-
	cal literature: Operating Instructions, Installation
	Instructions, Installation Report / Warranty Passport,
	Wiring References, Pre-Installation, Dimensions, Tech-
	nical Data. Keep this literature for quick and easy refer-
	ence.
	In order to protect your warranty rights, please fill out the
	“Installation Report / Warranty Passport” provided
	together with the technician immediately after installa-
	tion of the unit.
	Read the Operating Instructions to familiarize yourself
	with the unit before taking radiographs on the patient.
	Please observe the Radiation Protection Regulations
	and Warning and Safety Notes.
	These Operating Instructions assume a thorough famili-
	arity with the SIDEXIS software.
	Your
	ORTHOPHOS Team

Maintenance	To ensure the safety of the patient, the operators and
	third parties, equipment inspections and maintenance
	work must be carried out at specified intervals in order to
	guarantee the operational safety and functional reliability
	of your product.
	It is the responsibility of the operator to ensure that the
	inspections and maintenance work are carried out.
	In the event that the operator fails to fulfil the obligation
	to carry out inspections and maintenance work or
	ignores error messages, Sirona Dental Systems GmbH
	or their contracted dealer cannot assume liability for any
	damage attributable to this.

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Sirona Dental Systems GmbH

List of Contents

1	Warning and Safety Notes	........................................................................................................	5
2	Technical Description ...............................................................................................................		8
	2.1 ..................................................................................................	Technical Data	8
3	Operating Controls and Displays...........................................................................................		12
	3.1 .................................................................................................................	Unit	12
	3.2 ........................................................................................................	Multitimer	13
4	Accessories .............................................................................................................................		14
	4.1 .........................................................................................	Rests and supports	14
	4.2 .............................................................................	Hygienic Protective Covers	14
	4.3 ....................................................................................................	Service Tool	14
5	Exposure Programs ................................................................................................................		15
	5.1 .....................................................................................................	P1 Program	15
	5.2 ...................................................................................................	P11 Program	15
	5.3 .......................................................................................	P6.1 / P6.2 Program	16
6	Operation..................................................................................................................................		17
	6.1 ..................................................................................	Preparing the Exposure	17
	6.2 ....................................................................................	Positioning the Patient	20
	6.3 ......................................................................	Selecting Data at the Multitimer	25
	6.4 ..................................................................................	Releasing the Exposure	26
7	Programming ...........................................................................................................................		29
	7.1 .................................................................................	Programming Procedure	29
	7.2 ............................................................................	Adjustment of the Exposure	29
8	List of Help Messages H3/H4..................................................................................................		30
9	Program Values .......................................................................................................................		31
	9.1 ......................................	Program Values world - wide (except USA and Asia)	31
	9.2 ......................................................................................	Program Values USA	32
	9.3 ......................................................................................	Program Values Asia	33
10	Care the surfaces ....................................................................................................................		34
11	Error Messages........................................................................................................................		35
12	Inspection and maintenance ..................................................................................................		36

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Sirona Dental Systems GmbH

1 Warning and Safety Notes

Labeling of warning and safety information	In order to prevent injury to persons and damage to the
	equipment you must also read the warning and safety
	notes given in these Operating Instructions. These are
	emphasized with ATTENTION and CAUTION.
Intended use	This unit has been designed for use in creating pano-
	rama radiographic exposures.
	This unit must not be used in areas where there is a risk
	of explosion.
General safety information	As manufacturers of electro-medical products, we can
	assume responsibility for safety-related performance of
	the equipment only if maintenance, repair and modifica-
	tions are carried out only by us or agencies we have
	authorized for this purpose, and if components affecting
	safe operation of the unit that may be needed are
	replaced with original parts.
	We suggest that you request a certificate showing the
	nature and extent of the work performed, from those who
	carry out such work, and specify that the certificate show
	any changes in rated parameters or working ranges, as
	well as the date, the name of the firm, and a signature.
	For reasons of product safety, only original Sirona
	accessories approved for this product, or accessories
	from third parties which have been released by Sirona
	may be used. It is the user's risk when using non-
	released accessories.
	Exposures of patients may only be taken if the unit func-
	tions fault-free.
	Never leave the patient unattended in the unit.
	Instructions for avoiding, recognizing and correcting
	unintended electromagnetic effects:
	The ORTHOPHOS 3 DS X-ray System is a unit of class
	A (classification according to CISPR 11, EN 60601-1-2:
	1993 based off IEC 60601-1-2). This unit may be oper-
	ated in a residential area, provided it is used under the
	responsibility of a trained medical operator.
Safety measures during switch-on	Following extreme temperature fluctuations, condensate
	formation may occur; therefore please do not switch on
	the device until normal room temperature has been
	reached (see chapter "Technical Description").
	When switching on the unit, there must not be a patient
	positioned in the unit.
	If a fault occurs which requires switching the unit off and
	then back on again, the patient must be taken out of the
	unit at the latest before switching it on again!

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1 Warning and Safety Notes

Sirona Dental Systems GmbH

Interference with electromedical devices by radio telephones

To guarantee the operational safety of electromedical devices, it is recommended that the operation of mobile radio telephones in the medical practice or hospital is prohibited.

Malfunction of electronic units/devices which are worn on the patient's body.

In order to prevent failure of electronic units and data storage devices, e.g. radio-controlled watch and telephone card, etc., it is essential that these be removed prior to X-ray exposure.

Radiation Protection		Observe the applicable health physics regulations.The
		radiation protection facilities should be used.
		The operator should remain as far away from the X-ray
		tube as the cable of the release button permits.
		With the exception of the patient, no other persons
		may remain in the room while the exposure is being
		made.
		Under exceptional circumstances a third person, how-
		ever not belonging to the dental practice, may then
		assist. Maintain visual contact with the patient and the
		unit during the exposure.
		In case of faulty operation, discontinue the exposure by
		releasing the exposure button.
Disassembly and reinstallation		For disassembly and reinstallation of the unit proceed as
		described in the installation instructions for new installa-
		tion to ensure perfect function of the unit and its stability.
Disposal		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.
		Your product is marked with the adjacent symbol. Dis-
		posal of your product with domestic
		refuse is not compatible with the objectives of environ-
		mentally sound recycling/disposal.
		The black bar underneath the "garbage can" symbol
		means that it was put into circulation after Aug. 13, 2005.
		means that it was put into circulation after Aug. 13, 2005.
		(see EN 50419:2005)
		Please note that this product is subject to Council Direc-
		tive 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 prod-
		uct is required.
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Sirona Dental Systems GmbH 1 Warning and Safety Notes

Laser light localizers used This product incorporates a laser of class 1.

The light localizers serve for the correct positioning of the patient.

They must not be used for other purposes. A minimum distance of 100mm must be maintained between the eye and the laser. Do not look into the beam. Safety operation is described in Section 6.2.

The light localizers may be switched on only if they function fault-free. Repair work may be carried out only by authorized personnel.

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2 Technical Description	Sirona Dental Systems GmbH
2.1 Technical Data

2 Technical Description

2.1 Technical Data

Nominal line voltage:

Permissible line voltage fluctuation:

Nominal current:

Nominal frequency:

Power line resistance:

Fuse at the distribution panel:

Rating:

Tube voltage:

Tube current:

Curve form of high voltage:

Rotation time:

Exposure time:

Reproduction scale:

Focus size, according to IEC 336, measured in central ray:

Focus marking:

Automatic exposure blockage (see page 27):

Equipment of protective class I

Protection against electric shock:

Protection against penetration of water: Mode of operation:

Long time power rating:

Target material:

Loading factors concerning leakage radiation: Leakage radiation:

208V / 230V - 240V~

±10%

9.7A

50/60Hz

max. 0.8 Ohm

20A slow blow

2.1kW

60 – 80 kV

6 – 11mA

high frequency

multipulse Residual ripple ≤ 4kV

see page 31

With P1 program, medium mandibular arch (plane center) ca. 1:1,19. The image at the image receiver is approximately 19% larger than the real proportions.

0,5mm

The duration of the exposure blockage (cool-off period) depends on the kV/mA step set and the actually triggered radiation time. Depending on the tube load, pause times up to 200s are set automatically.

Example: For P1 program with exposure data 74kV/10mA and a radiation time of 11.3s a pause of 200s results.

Type B equipment

Ordinary equipment (without protection)

Continuous operation

64W

Tungsten

1.1mA / 80 kV

≤ 1mGy/h

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Sirona Dental Systems GmbH	2 Technical Description
	2.1 Technical Data

Source - Image receptor distance:

Transport and storing temperature:

Relative humidity:

Permissible operating temperature:

Sensor (image receptor):

Type:

External dimensions:

Active sensor surface:

Resulting image format:

Detail recognition:

Minimum requirements for the PC systems:

Hard disk:

RAM:

Drives:

Operating system:

Graphics system:

Network:

Communication connection:

Laser light localizer

Magnitude:

Max. radiant power:

Pulse duration:

497mm

-40°C – +70°C (-40°F – 158°F)

10% – 95%

According to IEC 601-1 between +10°C and +40°C (50°F – 104°F)

Digital CCD-technology line sensor, can be plugged to Panorama position.

280mm x 120mm x 35mm

Panorama: 138 mm x 5.9 mm

Panorama: depends on selected program, max. 138 x 288mm

Panorama: 0.09mm pixel size

>2 GByte / database

>50 MByte / SIDEXIS installation

at least 64 MB

CD-ROM

3.5" diskette (one per system / network)

MOD drive min. 640 MByte (one per system / network)

Windows 98

Windows NT 4.0 / Service Pack > 5

Resolution at least 1024 x 768 pixels, color depth at least 8 bit

10 / 100 MBit Ethernet

RJ45 for LAN cable

300mm long, 5mm wide

350J/m2

100s

ORTHOPHOS 3 DS has been inspected by the VDE Testing and Certification Institute for compliance with EN 60601- 1, EN 60601-2-28 and EN 60601-1-3 and has been found to comply with these regulations.

Original language: german

This product is provided with a CE marking in accordance with the regulations stated in the Directive 93/42/ EEC of June 14, 1993 concerning medical products.

0123

Reg. No.: China

SFDA (I) 20053301583

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2 Technical Description	Sirona Dental Systems GmbH
2.1 Technical Data

Cooling curve for the tube housing:

	HUx104		1HU = 1,35 Joule
130
120
120
110
110
100
100
90
90
80
80
70
70
60
60
50
50
40
40
30
30
20
20
10																t
10


															min
0	20	40		60	80	100	120	140	480	160	180	200	220	240	min

Anode cooling caracteristic:

HUx103 1HU = 1,35 Joule

							t
0	1	2	3	4	5	6	min

Heating curve for tube housing:

	HUx103		1HU = 1,35 Joule
1000
							t
0	1	2	3	4	5	6	h

Reference axis:
Reference axis	Anode angle
	7°
	10°

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Sirona Dental Systems GmbH	2 Technical Description
	2.1 Technical Data

Radiation fields of the laser light localizers:

60°

32°

5°	60°
	60°
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3 Operating Controls and Displays	Sirona Dental Systems GmbH
3.1 Unit

3 Operating Controls and Displays

3.1	Unit
			4	3	2
			9		10
1
	11	7	8		5	6

1.Main switch

2.Patient positioning mirror

3.Head holder with adjusting knob for temple supports

4.Image receiver

5.Diaphragm

6.Diaphragm wheel

7.Height adjustment buttons

Additional function: key ↑ switches light localizer on

8.Knob for image receiver removal or insertion

9.Height adjustment

Light localizer horizontal light beam FH

10.Light localizer central light beam

11.Multitimer

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+ 26 hidden pages

Sirona Orthophos 3 DS User Manual

1 Warning and Safety Notes

2 Technical Description

2.1 Technical Data

3 Operating Controls and Displays

3.1 Unit