Sirona Orthophos 3 User Manual

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General information	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3

General information

Dear customer,	Thank you for purchasing your new Sirona X-ray unit
	ORTHOPHOS® 3 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 reference.
	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.
	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
Operating Instructions ORTHOPHOS 3

List of Contents

1

2

3

4

5

6

7

8

9

Warning and Safety Notes.............................................................................................		5
Technical Description ....................................................................................................		9
2.1	Technical Data....................................................................................................................................	9
Operating Controls and Displays ...............................................................................		13
3.1	Unit ...................................................................................................................................................	13
3.2	Multitimer ..........................................................................................................................................	14
Accessories ..................................................................................................................		15
4.1	Rests and supports...........................................................................................................................	15
4.2	Hygienic Protective Covers...............................................................................................................	15
4.3	Service Tool......................................................................................................................................	15
Exposure Programs .....................................................................................................		16
5.1	Program P 1......................................................................................................................................	16
5.2	Program P 11....................................................................................................................................	16
5.3	Program P 6.1 / P 6.2 .......................................................................................................................	17
Operation ......................................................................................................................		18
6.1	Preparing the Exposure ....................................................................................................................	18
6.2	Positioning the Patient ......................................................................................................................	20
6.3	Selecting Data at the Multitimer........................................................................................................	25
6.4	Releasing the Exposure....................................................................................................................	26
Programming ................................................................................................................		28
List of Help Messages H3 ............................................................................................		29
Program Values ............................................................................................................		30
9.1	Program Values world-wide (except USA and Asia) ........................................................................	30
9.2	Program Values USA........................................................................................................................	31
9.3	Program Values Asia ........................................................................................................................	32

10

11

12

Care the surfaces .........................................................................................................	33
List of Error Messages.................................................................................................	34
11.1 Error Messages ................................................................................................................................	34
Inspection and Maintenance .......................................................................................	35

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List of Contents	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3

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Sirona Dental Systems GmbH	1 Warning and Safety Notes
Operating Instructions ORTHOPHOS 3

1 Warning and Safety Notes

Labeling 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. They are
	highlighted by the caption
	NOTE, CAUTION or WARNING.
Symbols used	Observe accompanying documents
	(on name plate)
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.
Maintenance and repair	As manufacturers of electromedical equipment we can
	assume responsibility for safety-related performance of
	the equipment only if maintenance and repair are car-
	ried out only by us or agencies we have authorized for
	this purpose, and if components affecting safe operation
	of the unit are replaced with original spare parts.
	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 could impair the
	safety of operators, patients or third persons are prohib-
	ited by legal provisions!
	For reasons of product safety, this product may be
	operated only with original Sirona accessories or acces-
	sories manufactured by third parties expressly approved
	by Sirona. The user is responsible for dangers resulting
	from the use of non-approved accessories.
	If any devices not approved by Sirona are connected,
	they must comply with the applicable standards:
	IEC 60950 for information technology equipment (e.g.
	PCs), and IEC60601-1 for medical electrical equipment.
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-rays of patients	X-rays of patients must be taken only when the system
	works without errors.

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1 Warning and Safety Notes	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3
	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)	Medical electrical devices are subject to special precau-
	tionary measures regarding EMC. They must be
	installed and operated as specified in the document
	"Installation Requirements".
	Information on avoiding, recognizing and eliminating
	unintended electromagnetic effects:
	The ORTHOPHOS 3 acquisition unit is a Class B device
	(classified according to CISPR 11, EN 60601-1-2: 2001
	based on IEC 60601-1-2).
	This system may be operated in a residential area.Port-
	able and mobile HF communication devices can influ-
	ence medical electrical equipment. The use of mobile
	telephones in the practice or hospital area therefore
	must be prohibited.
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 off and subse-
	quent switching on of the unit, the patient must be
	removed from the unit before switching it on again at the
	latest!
Emergency Stop	If parts of the unit contact the patient during the rotational
	movement , let go of the exposure release button
	(X-Ray) immediately and stop the unit by actuating the
	unit main switch or an Emergency Stop switch!

Disturbance of electronic devices worn on the patient’s body.

Radiation protection

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.

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Sirona Dental Systems GmbH

Operating Instructions ORTHOPHOS 3

Hygiene information

Dismantling and reassembly

Disposal

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1 Warning and Safety Notes

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, interrupt the exposure immediately by releasing the exposure release button.

The protective covers must be exchanged for each new patient and the sterilizable accessories must be sterilized to prevent any transmission of infective agents which might cause serious illnesses.

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

For dismantling and reassembly of the device, proceed according to the Installation Instructions for new installation in order to guarantee the operability and stability of the system.

It applies generally that the national regulations have to be complied with when disposing of this product. Please observe the regulations applying in your country.

Within the European Economic Community the directive 2002/96/EEC (WEEE) for electrical and electronic devices requires environmentally compatible recycling / disposal.

Your product is marked with the adjacent symbol. With the goal of environmentally compatible recycling / disposal, your product must not be disposed of with the domestic refuse.

The black bar under the "refuse bin" symbol means that it has been put onto the market after 13.08.2005. (See EN 50419:2005)

Please note that this product is subject to the directive 2002/96/EEC (WEEE) and laws applicable in your country and must be sent for environmentally compatible recycling / disposal.

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 your product should be finally disposed of.

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1 Warning and Safety Notes	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3
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 opera-
	tion is described in Section 6.2.
	The light localizers may be switched on only if they func-
	tion fault-free. Repair work may be carried out only by
	authorized personnel.

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Sirona Dental Systems GmbH	2 Technical Description
Operating Instructions ORTHOPHOS 3

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: Year of manufacture

Mode of operation:

Long time power rating:

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208V / 230V - 240V

±10%

max 9.7A

50/60Hz

max. 0.8Ohm

20A slow blow

2.1kW

60 – 80kV

6 –11mA

high frequency

Multipuls Residual ripple ≤4kV

see page 30

see page 30

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)

(on the name plate)

Continuous operation

64W

9

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2 Technical Description	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3

Target material:

Loading factors concerning leakage radiation: Leakage radiation:

Transport and storing temperature:

Relative humidity:

Permissible operating temperature:

Source - Image receptor distance: Panorama

Cassette format:

Panorama

USA/CANADA

Korea

Laser light localizer

Magnitude:

Max. radiant power:

Pulse duration:

10

Tungsten

1.1mA / 80kV

≤1mGy/h

-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)

497mm

15cm x 30cm (6" x 12")

8 x 10in.

10 x 8in.

300mm long, 5mm wide

350J/m2

100s

ORTHOPHOS 3 has been inspected by the VDE Test-

ing and Certification Institute for compliance with EN 60 601-1, / 1998

EN 60 601-2-7 / 1998

EN 60 601-2-28 / 1998,

EN 60 601-1-3 / 1998,

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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Sirona Dental Systems GmbH

2 Technical Description

Operating Instructions ORTHOPHOS 3

Cooling curve for the tube housing:

	HUx104	1HU = 1.35 Joule
130
120
110
100
90
80
70
60
50
40
30
20
10														t
0	20	40	60	80	100	120	140	480	160	180	200	220	240	min

Anode cooling characteristic:

	HUx103		1HU = 1.35 Joule
20
15
10
5
							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
		7°								Anode angle
								10°
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2 Technical Description	Sirona Dental Systems GmbH
	Operating Instructions ORTHOPHOS 3

Radiation fields of the laser light localizers:

60°

32°

5°	60°

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