Sirona Orthophos Plus User Manual

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	Sirona Dental Systems GmbH
Dear Customer	Thank you for purchasing your new ORTHOPHOS Plus
	X-ray unit for panorama planigraphy.
	Standard radiographs (jaw region), sinus radiographs
	(maxillary sinuses) and temporomandibular joint radio-
	graphs in digital exposure technique are possible.
	For this unit we have provided you with a set of techni-
	cal literature. Keep this literature for quick and easy
	reference.
	In order to protect your rights under Sirona warranty, the
	purchaser must register the unit by filling out the War-
	ranty Passport provided together with the technician
	immediately after installation 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 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. (IEC 601-1 / DIN EN 60601-1, etc.).
	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 igno-
	res error messages, Sirona Dental Systems GmbH or
	their contracted dealer cannot assume liability for any
	damage attributable to this.

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List of Contents

List of Contents

1	Warning and Safety Notes	........................................................................................................	5
2	Technical Description ...............................................................................................................		8
3	Operating Controls and Displays...........................................................................................		12
	3.1 .................................................................................................................	Unit	12
	3.2 ...............................................................................................	Control Panel A	12
	3.3 ..........................................................................................	Help LED - displays	13
	3.4 ........................................................................................................	Multitimer	13

4 Accessories .............................................................................................................................		14
4.1	Rests and supports.........................................................................................	14
4.2	Hygienic Protective Covers.............................................................................	15
4.3	Service Tools ..................................................................................................	15

5	Exposure Programs ................................................................................................................		16
	5.1	P 1 Program....................................................................................................	16
	5.2	P 2 Program....................................................................................................	16
	5.3	P3 Program.....................................................................................................	17
	5.4	P4 Program.....................................................................................................	17
	5.5	P5 Program.....................................................................................................	18
	5.6	P6.1 / P6.2 Program .......................................................................................	18
	5.7	P7.1 / P7.2 Program .......................................................................................	19
	5.8	P8 Program.....................................................................................................	19
	5.9	P9 Program.....................................................................................................	20
	5.10	P10 Program...................................................................................................	20
	5.11	P11 Program...................................................................................................	21
	5.12	P12 Program...................................................................................................	21
	5.13	P13 Program...................................................................................................	22
	5.14	P14 Program...................................................................................................	22
	5.15	P15 Program...................................................................................................	23
	5.16	P16 Program...................................................................................................	23

6	Operating..................................................................................................................................		24
	6.1	Preparing the Exposure ..................................................................................	24
		Loading the Film Cassette .......................................	24
		Insert Accessories....................................................	24
		Contact Spacer and Head Positioner.......................	24
		Switching ON the Unit ..............................................	25
		Primary Diaphragm ..................................................	25
		Digital Displays.........................................................	25
	6.2	Positioning the Patient ....................................................................................	27
		Preparations.............................................................	27
		Exposure with Chin Rest and Bite Block..................	27
		The Frankfurt horizontal FH .....................................	29
		Digital displays .........................................................	29
		Exposure with Chin Rest and Bar ............................	30
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List of Contents Sirona Dental Systems GmbH

	Exposure with Bite Block or Contact Segment without
	Chin Support ............................................................	31
	. . . with Bite Block ....................................................	31
	. . . with Contact Segment ........................................	31
	The Frankfurt Horizontal FH.....................................	32
	Digital displays .........................................................	32
	Exposures of the Temporomandibular Joint, P4 – P9
	Programs with Head Positioner................................	33
6.3	Final Preparations...........................................................................................	34
	Selecting the Exposure Program..............................	34
	Automatic Exposure Selection AES (ABV)...............	35
	Select Exposure Data...............................................	35
	Anomaly Button A.....................................................	36
6.4	Releasing the Exposure..................................................................................	37
	Interrupting the Exposure .........................................	38
	Automatic Exposure Blockage .................................	38
	Error Message E... ...................................................	38

7	Programming ...........................................................................................................................	39
	Programming Procedure ..........................................	39
	Adjustment of the Exposure .....................................	40
8	Help Messages H3...................................................................................................................	41
9	Program Values .......................................................................................................................	42
	9.1 Program Values ..............................................................................................	42
10	Care the surfaces ....................................................................................................................	43
11	List of Error Messages............................................................................................................	44
12	Inspection and Maintenance ..................................................................................................	46

12.1Annual inspection performed by the operator or other authorized personnel . 46

12.2	Maintenance performed by the service technician..........................................	46
12.3	Checking image quality...................................................................................	46

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1 Warning and Safety Notes

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 CAUTION and 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.
	The system may only be operated by skilled or prop-
	erly trained personnel.
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1 Warning and Safety Notes Sirona Dental Systems GmbH

	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
	Plus 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 resi-
	dential area.
	Portable and mobile HF communication devices can
	influence medical electrical equipment. The use of
	mobile telephones in the practice or hospital area there-
	fore must be prohibited.
Precautionary measures when switching on the	Following extreme temperature fluctuations, condensa-
unit	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.

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.

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		In case of malfunctions, interrupt the exposure immedi-
		ately by releasing the exposure release button.
Hygiene information		The protective covers must be exchanged for each new
		patient and the sterilizable accessories must be steril-
		ized 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.
Dismantling and reassembly		For dismantling and reassembly of the device, proceed
		according to the Installation Instructions for new installa-
		tion in order to guarantee the operability and stability of
		the system.
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.
		(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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2 Technical Description

Sirona Dental Systems GmbH

2 Technical Description

Nominal line voltage:

Permissible fluctuation with 230 V: with 208 V:

Nominal current:

Nominal frequency:

Power line resistance:

Fuse at the distribution panel:

Rating:

Tube voltage:

Tube current:

Curve form of high voltage:

Program duration:

Exposure time:

Reproduction scale:

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

Focus marking:

Automatic exposure blockage (see page 38):

Equipment of protective class I

Protection against electric shock:

Protection against penetration of water:

208V / 230V AC

+6, –10% ±10%

12A

50/60Hz

max. 0,8Ohm

16A slow blow

2,8kVA

60 – 90kV

9 –16mA

High frequency, multipulse

Residual ripple ≤4kV

see page 42

see page 42

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 between 8s and 300s are set automatically.

Example: For P1 program with exposure data 80kV/14mA and a radiation time of 14.1s a pause of 255s results.

Type B equipment

Ordinary equipment (without protection)

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Sirona Dental Systems GmbH 2 Technical Description

Year of manufacture	(on the name plate)
Mode of operation:	Continuous operation
Long time power rating	60W
Target material	Wolfram
Loading factors concerning leakage radiation	0,57mA / 90kV
Source - Image receptor distance	497 mm
Transport and storing temperature:	-40°C – +70°C (-40°F – 158°F)
Relative humidity:	10% – 95%
Permissible operating temperature:	According to IEC 601-1 between +10°C and +40°C
	(50°F – 104°F)

ORTHOPHOS Plus is in compliance with EN 60 601-2-7 / 1998

ORTHOPHOS Plus is in compliance with IEC 601-2-28 / 1993

ORTHOPHOS Plus is in compliance with IEC 601-1-3 / 1994

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

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	60		120	180	240	300		360	420	480	540	600	660	720	min
	HUx103										Anode cooling caracteristic:
25			1HU = 1,35 Joule
20
15
10
5
							t
0	1	2	3	4	5	6	min
HUx103											Heating curve for tube housing:
			1HU = 1,35 Joule
1350
							t
0	1	2	3	4	5	6	h
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2 Technical Description

Reference axis

Reference axis

7°

10°

Anode angle

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3 Operating Controls and Displays

Sirona Dental Systems GmbH

3 Operating Controls and Displays

3.1 Unit

1

2

3

4

5

6 7 8

9

10

11 12 13 14

A

Multitimer

3.2 Control Panel A

1Main switch

2Patient positioning mirror

3Height adjustment for the FH light line

4Adjusting knob for temple supports

5Forehead support

6Temple supports

7Cassette holder

8Cassette carriage

9Film cassette

10Film cassette stop

11Button for removing bite block

12Diaphragm wheel

13Locking button

14Diaphragm

Return button R

Light localizer ON / OFF

Anomaly button A + – with LED display Height adjustment display in mm

Height adjustment

Forehead support adjustment display in mm

Forehead support adjustment

←towards column / away from column →

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3 Operating Controls and Displays

3.3 Help LED-displays

	13	16
	14
	15	17
		18
		19

See the inside of the door for a list of appropriate H3 help messages (see page 41).

13Cassette holder not in position

14Forehead support position

15Exposed film inserted

16X-ray tube position

17Cool-down interval

18Diaphragm adjustment

19Height adjustment

3.4 Multitimer

P I

62

I6

P I

I4.I

62

I6

”Unit ON” LED

X-ray ON indicator

Exposure button

Digital display for exposure program / exposure time with – + buttons for exposure programs

Digital display for kV/mA values

with – + buttons for kV/mA matched values

Patient symbols programmed kV/mA values

Memory program button kV/mA matched values

AES button (Automatic Exposure Selection)

Rotation test button T without radiation

Return button R

The LED blinks when the system is not ready (ReadyLED).

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4 Accessories

Sirona Dental Systems GmbH

4 Accessories

4.1 Rests and supports

Press shortly to open.

135° C

275° F

E*

A*

F C*

D*

						H*
	B*
L							G*

N*

J

M*

K*

14

The receptacles behind the door are for the storage of accessories and hygienic protective covers.

Handles and * marked accessories can be sterilized.

Sterilize only in an autoclave at 135°C, 2.1 bar (275°F, 30PSI).

Untightened handles can be removed for sterilization as shown.

For tightened handles, please use the hygienic protective covers shown on the next page.

For reorders:

A*	Forehead support strip
	(5 pcs)	Order No. 89 21 835
B*	Chin rest complete,
	incl. 5xE, 1xF, C, D, R, S
		Order No. 18 88 762
C*	Bar for chin rest
		Order No. 59 61 461
D*	Intermediate piece
		Order No. 14 49 227
E*	Bite block
	(10 pcs)	Order No. 18 88 887
F	Stick for bite block
	(5 pcs)	Order No. 18 88 895
G*	Standard yellow bite block
(5 pcs)		Order No. 89 21 843
H*	Standard yellow contact segment
	for subnasals
	(5 pcs)	Order No. 89 31 545

JHead positioner complete, incl. 4xK

		Order No. 18 88 770
K*	Ear fixation
	(10 pcs)	Order No. 18 88 838
L	Contact spacer
		Order No. 33 10 336
M*	Bite block blue, for sinus exposures
	(5 pcs)	Order No. 89 21 850
N*	Contact segment, blue,
	for subnasals with sinus and paranasal
	tomographic exposures
	(5 pcs)	Order No. 89 31 552

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4 Accessories

4.2 Hygienic Protective Covers

					Before each exposure, the hygienic protective covers
					(disposable) should be attached.
					For better illustration of the components, the following
					figures are shown without the hygienic protective covers.
					For orders:
					P For forehead support and handles
	P		S			(500 pcs)	Order No. 33 14 098
						Dimensions:
						210mm (140mm) x 57 mm
					R	For chin rest
						(100 pcs)	Order No. 59 32 603
					S	Dimensions:	75mm x 60mm
						For bite block
						(500 pcs)	Order No. 33 14 072
					T	Dimensions:	43mm x 21mm
						For bite block and contact segment
						(500 pcs)	Order No. 33 14 080
		R				Dimensions:	80mm x 40mm

T

4.3 Service Tools
4		Tools supplied with the unit and needed for the mainte-
		nance and/or service must remain with the unit.
		(Adjustment set).
		1	Special wrench
1			Order No. 52 43 605
		2	Needle phantom
			Order No. 89 31 925
	2	3	Test block
			Certified component of the unit.
		4	Beam alignment tool
3			Order No. 89 31 800
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