Fona Xpan Operator Manual Gb

FONA XPan Operating Instructions

FONA XPan – Operating Instructions

FONA XPan Operating Instructions English Edition Version 111104 November 2011 Code 69 682 70110 Manufactured by FONA S.r.l. Via Idiomi 1/8-33 - 20090 Assago (MI) Italy Distributed by FONA Dental s.r.o. Stefanikova 7 SK-811 06 Bratislava, Slovakia www.fonadental.com

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Table of Contents 1.

INTRODUCTION .....................................................................................5 1.1 Destination of Use.............................................................................5 1.2 Warning for the User.........................................................................5 1.3 Caution .............................................................................................6 1.4 Safety ................................................................................................6 2. GENERAL ................................................................................................7 2.1 Indications for Use ............................................................................7 2.2 Operation ..........................................................................................8 2.3 Control panel ..................................................................................10 2.4 Functions ........................................................................................11 2.5 Cassette Preparation ........................................................................13 2.6 Panoramic Magnification Factor .....................................................13 2.7 Ceph Magnification Factor..............................................................13 2.8 Provisions for safety........................................................................14 3. PANORAMIC RADIOLOGY.................................................................14 3.1 Panoramic Programs .......................................................................14 3.2 Trial Session ...................................................................................14 3.3 Technique Factors ...........................................................................15 3.4 Positioning Accessories ..................................................................15 3.5 Collimator for Panoramic ................................................................16 3.6 The Aiming Lights ..........................................................................16 3.7 Resetting Carriage in Patient Entry Position ...................................16 3.8 Patient Positioning ..........................................................................17 3.9 TMJ projections ..............................................................................19 3.10 Maxillary Sinuses............................................................................19 3.11 Panoramic Exposure .......................................................................20 4. CEPHALOMETRIC RADIOLOGY .......................................................21 4.1 Cephalometric Programs .................................................................21 4.2 Technique Factors ...........................................................................21 4.3 Collimator for Cephalometric .........................................................22 4.4 Film Formats and Cassette Placement .............................................23 4.5 Cephalometric Exposure .................................................................23 5. MAINTENANCE....................................................................................24 5.1 Cleaning ..........................................................................................24 5.2 Disinfection.....................................................................................24 5.3 Technical maintenance ....................................................................24 5.4 Disposing of Obsolete Equipment ...................................................25 111104

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6. CLASSIFICATION.................................................................................25 Appendix A Alarm Messages ..........................................................................26 Appendix B Icons ............................................................................................27 Appendix C Technical Data .............................................................................28 Appendix D Labels ..........................................................................................29 Appendix E Cooling Curves ............................................................................30 Appendix F Fuse Table ...................................................................................31

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1.

INTRODUCTION

FONA XPan /Ceph are high quality panoramic and cephalometric dental X-ray systems based on latest technologies, featuring software driven multi-projection capabilities, for optimal diagnostic result in the day to day routine. Units are is manufactured under a Quality Control System that grants full compliance to specifications. The Operating Instructions and the Service and Installation Manual supplied with the system are integral part of the product. The original language of the Operating Instructions is English.

1.1

Destination of Use

The family of FONA XPan /Ceph products includes traditional systems equipped with cassette for use of films  either for chemical processing  or phosphor plates for laser scanning and digital acquisition. Two versions are available  Panoramic Solo (Pan Solo) and  Panoramic and Cephalometric (Pan Ceph) with arm for teleradiography. Each system can be equipped with temporo mandibular resting bars, on request. A panoramic cassette holder for 24x30 cm cassette is optionally available.

1.2

Warning for the User

The user has the following responsibilities:  Use the system following the instructions and recommendations contained in this user manual.  Keep the machine in perfect working condition following the maintenance instructions given by the manufacturer. Failure to observe the instructions relieves the manufacturer or his agent from any responsibility for injury, damage or non-conformities that may derive there from.  Promptly notify the competent Health Authority and the manufacturer in the event of an accident involving this medical device and/or operations that may cause death or put the patient and/or the user at risk. The type and serial numbers of the components involved, indicated on the external labels, are to be communicated to the manufacturer.

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1.3

Caution

X-ray equipment produces ionizing radiation that may be harmful if not properly controlled. It is therefore recommended that the equipment be operated by trained personnel only, in accordance with existing law. Even if compliant to specifications of electromagnetic compatibility, it is recommended not to use the equipment in presence of external electromagnetic fields, such as those generated by cellular phones, which might interfere with the electronic circuits of the system.

1.4

Safety

 Electrical.  Trained and qualified technicians only are authorized to remove covers and have access to power circuits.  Power supply lines must comply with safety legislation and have ground terminals for protective earth connection.  Switch the equipment off and possibly disconnect it from mains (room switch) before cleaning or disinfecting the unit.  Mechanical.  Make sure that fingers or other parts of the patient or of the operator are not pinched during the movement of the unit.  Explosion.  The equipment cannot be used in presence of flammable gases or vapours.  Radiation.  Trained and qualified personnel only are authorized to operate the equipment always complying with existing law for Radiation Protection.  Safety distance. The operator is invited to stay 3 meters from the column (in the designated significant zone of occupancy) or exit the room, always keeping an eye to the patient, ready to terminate the exposure in case of need.  Make sure that the equipment is not left unattended.  Environmental.  The machine contains components that cannot be disposed of in the environment and it must be disposed of in accordance with the laws in force.

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2.

GENERAL

2.1

Indications for Use

The family of FONA XPan /Ceph imaging systems includes diagnostic X-ray equipment to produce panoramic and cephalometric radiographs of the dentomaxillofacial area for diagnostic examination in any dental practice. Panoramic imaging in dental 4 2 4 X-ray is considered a routine procedure with which to perform a complete examination of 1 the dental arch (1), of the maxillary (2) and mandibular (3) regions, and that of the Temporo 3 Mandibular Joints (TMJ) (4). Available panoramic examinations include:  Panoramic for adults.  Panoramic for children with reduced exposure.  Left side of dentition.  Right side of dentition.  Anterior part of dentition.  TMJ, habitual occlusion and open at maximum extent (placed on same film for analog systems).  Frontal view of nasal (maxillary) sinuses Extraoral radiology is completed with teleradiograpfhy for cephalometric applications. Cephalometric projections include:  Latero Lateral (LL) radiograph of the skull with soft tissue filter for adult and child.  Antero Posterior (AP) or Postero Anterior (PA) radiograph of the skull.  Wrist radiograph.

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Operation

2.2

A vertical carriage (A) , to which the power supply cord and the exposure hand-switch (L) are connected, can be moved vertically on the column (B) . A rotating unit (C) comprising the tubehead generator(D), cassette holder (E) and control panel (F) is connected to the

G B

A C

I

F

D E J

K

vertical carriage. The stand is fixed to a wall with a wall holder (G) . Alternatively an optional self-standing base (H) fixed to the floor can be used. The arm carrying the cephalostat (I) with the Ceph cassette holder (J) is fixed to the vertical carriage. The diagnostic equipment can be raised or lowered with the up and down keys to activate the motor (K). Panoramic picture of the dentition is performed by means of a narrow X-ray L beam scanning the patient from left to right. The cassette with the film moves at a variable speed with regard to the radiation beam during the exposure.

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SAFE ZONE OF OCCUPANCY FOR OPERATOR

3m 10 foot

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FONA XPan – Operating Instructions In order to have the roots of teeth falling into the “in-focus layer” adjustments of the carriage either backward or forward may be needed. A shift of the carriage is usually not required for patients with normal occlusion, but in case of overjet for class II or class II malocclusion, in order to have the roots of teeth falling into the “in-focus layer” adjustments of the carriage can be done using the displacement key (M) on control panel, with the help of the lateral light beam (N) Midsagittal light (P) is available to check for side rotation of head. Frankfurt plane can be adjusted (P) to verify backward or forward tilting of the head. Adaptation of the system to teleradiography is done by rotating the tube-head (D) in favour of the cephalostat and selecting the proper beam collimating window by rotating the disk below the tube-head (Q). The use of cassettes equipped with rare earth intensifying screens and light sensitive films reduce to minimum the radiation dose necessary for this type of application .

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M

O P

N

D

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2.3

Control panel 12

13

14

15 16

1 3 2 6

6 17

4 5

7

1 2

8

9

10

System ON

11 BACKWORD Shift (referred to patient) FORWORD Shift (referred to patient) PROGRAM number 1-7 for PAN 8-10 for CEPH

System READY

11 11

3

X-ray emission

12

4

PROGRAM Selection

13

SHIFT rotating arm in mm

5

PATIENT build: small, medium, large, very large

14

COLLIMATOR: PAN A, PAN B, CEPH

6

INCREASE/ DECREASE: kV (left), mA (right)

15

ALARM or ERROR: consult documentation

7

MOVEMENT in sequence/initialization

16

X-ray Indicator (Ionizing Radiation Emission)

8

LIGHT: LASER beams on (30 s)

17

X-RAY control button

9

TEST without radiation

18

UP movement

BACK to patient entrance position/Alarm reset

19

10

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Functions

2.4

A

Switching Unit ON Pressing the General Switch placed below the chin-rest, the unit is supplied and the green Led turns ON. Then the INIT function is started and after 7 s the message “RESET” appears.

B

Reset Function

By pressing the ARM MOVEMENT key the rotation arm, and, in case, the cassette carriage, automatically locate the reference points and terminate in “PATIENT ENTRY” position (rotating carriage at 90°, with tube-head placed to the right of the patient, cassette holder to the left).

C

Panoramic- Cephalometric Mode of Operation This function is applicable for units with cephalometric capabilities. The X-ray beam opening on the tube house assembly has to be directed towards the cassette holder (or digital sensor) for panoramic examinations and towards the cephalostat for cephalometric ones. In case of panoramic selection the applicable kV and mA values appears on the display. This last is replaced by mAs in case of cephalometry. For “analog” systems the panoramic or ceph cassette properly loaded has to be placed on the cassette holder paying attention to the applicable field. The set of programs from 1 to 7 are available in panoramic mode and those from 8 to 10 in cephalometric mode.

D

Raising or lowering the system The unit is equipped with a motor to raise or lower the carriage and fit the patient height by activating the UP or DOWN keys on the sides.

E

UP KEY

DOWN KEY

Examination Selection

By pressing key of program selection the desired examination can be activated, with the relevant code reported on the display. Patient size can be selected with the PATIENT key . The applicable technique factors are thus selected. Should them be corrected manually, the plus and minus keys can be used to increase or decrease the proposed values. To step back to the automatically proposed values, the PATIENT key can be pressed. 111104

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F

High Voltage Setting In case the proposed value of kV level has to be corrected, it can be done with the plus and minus keys on the left side of the display. The anode voltage can be set from 61 to 85 kV in steps of 3 kV. 61 64 64 67 70 73 76 79 82 85

G

Anode Current Setting In case the proposed value of mA level has to be corrected, it can be done with the plus and minus keys on the right side of the display. The anodic current can be set from 4 to 10 mA. 4.0 5.0 6.3 8.0 10

H

Time-Current Product Setting In Ceph mode the time-current product in mAs is used (at 10 mA fixed). In case the proposed value of mAs has to be corrected, it can be done with the plus and minus keys on the right side of the display. The mAs ranges from 2 to 40. 2.0 4.0 8.0 16 32 2.5 3.2

5.0 6.3

10 12

20 25

40

I

Collimator Selection In case of cephalometric units, the proper collimating window can be selected by rotation of the disk on the tube-house assembly. The code of the selected collimator therefore appears on the display under the COLLIMATOR mark . In case of incongruent selection the mark appears blinking.

YELLOW LIGHT

J

Exposure control The control unit takes care of both rotation and translation movements of the carriage and of film cassette together with X-ray generation during irradiation. A yellow light is emitted during irradiation and a sound buzzer is activated.

K

Error Handling The ERROR number is shown on the display with the red light ON (blinking). To reset the error condition, the RETURN key 12/32

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2.5

Cassette Preparation

A

Use of film with intensifying screens Make sure that the intensifying screens are clean. Be sure that the dark room is light proof and in case equipped with proper safety lights (please note that panoramic films are much more sensitive to light than intra-oral films and therefore safety lights good for intra-oral film processing may be not adequate). Always work with dry and clean hands. Insert the film into the cassette and close it firmly. As a general rule to avoid mistakes, unloaded cassettes are kept unlocked. Combination with speed 400 is recommended. Speed Screen type Film Type Light Color Manufacturer 250 Lanex Medium T Mat G GREEN Kodak 250 Curix Ortho Medium Dentus ST8G GREEN Agfa 400 Lanex Regular T Mat G GREEN Kodak 400 Curix Ortho Regular Dentus ST8G GREEN Agfa 400 Ektavision Ektavision GREEN Kodak

B

Use of Storage Phosphor Plates Cassettes to be used are without intensifying screens which are not compatible with storage phosphor plates. Make sure the plates are properly erased before loading them into the cassette.

2.6

Panoramic Magnification Factor

The shown size of the teeth in the radiograph is different than actual size. The distance focus–film is of 513 mm, the one focus–object is of 404 mm. The magnification factor of panoramic radiography (MFpan) can be computed as follows: MFpan = 513 / 404 which is about 1.27, i.e. 27% magnification. Magnification in panoramic is referred to the vertical size of incisor teeth with patient properly positioned.

2.7

Ceph Magnification Factor

The shown size of the skull in the radiograph picture is different than actual size. Distance focus–film is 1650 mm, the one focus–object is 1500 mm The magnification factor of Cephalometric radiography (MFceph) can be computed as follows: MF ceph = 1650 / 1500 which is 1.10, i.e. 10% magnification. 111104

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2.8

Provisions for safety

 Correct status of the unit and proper adjustment of movable parts are indicated by the READY light . If system is not in the READY condition, press the ARM MOVEMENT key to initialize the system.  After each exposure the unit enters a waiting period to cool down.  During the waiting time the READY indicator blinks and exposures cannot be made. Count down register is displayed.  If a failure happens when system is switched ON or during exposure, the ERROR indicator will light up. This indicator is also lit for incorrect operations (e.g. push-button released during exposure). The number displayed represents the error code (see appendix A). Press the ALARM RESET key to acknowledge and cancel the error indication.

3.

PANORAMIC RADIOLOGY

3.1

Panoramic Programs Icon

Program Standard panoramic on adult constant vertical magnification Child projection, with reduced exposure

14 s 13 s

Half Panoramic Left

7s

Half panoramic Right

7s

Frontal Dentition TMJ Lateral Projections Maxillary Sinus

3.2

Exposure time

4.9 s 2 x 1.75 s 12 s

Trial Session

 A trial session without irradiation can be started by pressing the TEST key push-button (9).  By pressing the exposure hand-switch under the TEST condition the unit performs normally, but X-rays are not generated. 14/32

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FONA XPan – Operating Instructions  To exit the TEST mode press again the TEST key.  After the execution of a trial exposure without radiation, the rotating carriage moves to the “patient entry” position, and exits from “test mode”.

Technique Factors

3.3

Default values are reported in the tables below for film-screen combination of speed 400. In case of use of receptors with different sensitivity, the technique factors have to be changed accordingly.  Increase of technique factors lead to darker radiographs.  Decrease of technique factors lead to lighter radiographs. Technique Factors Patient Size Adult Anodic Vol- Anodic CurChild Adult Panoramic & tage (kV) rent (mA) Panoramic TMJ & Sinus partial views 61 6.3 Small 64 6.3 Medium 67 6.3 Large 70 6.3 Extra large Small 73 6.3 Medium Small 76 6.3 Large Medium 79 6.3 Extra large Large 82 6.3 Extra large 85 6.3 Values of kV and mA are automatically set and indicated on the display upon selection of type of examination and patient size. In case a change is needed the relevant parameter can be corrected on the control panel by using the PLUS or MINUS keys on the right for mA and on the left for kV. The kV level is related to penetration of X-ray, i.e. the ability to go through the anatomical structures and build the image: the bigger the patient the higher the kV level.

Positioning Accessories

3.4

A bite block and a chin rest for edentulous patients are available as positioning devices. Temporal resting bars can be added as an option.

Bite Block

Chin Rest

Temporal Bars

WARNING. Only use the accessories indicated in this Operating Instructions. 111104

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3.5

Collimator for Panoramic

A single collimator slit is available on Pan Solo units for a standard image height of 13.5 cm on receptor. In Pan Ceph units with revolving collimator the Child projection uses a dedicated slit to further reduce the exposure dose.

3.6

The Aiming Lights

The unit is equipped with a set of LASER lights for the three alignment planes: Median Sagittal. It divides the head of the patient in left and right side. Check to be done for the light beam to fall in the middle of the face. Frankfurt Horizontal Plane. This beam source can be moved up and down to align just above the ear hole and allow the operator to check for correct orientation of the head (forward or backward tilting of the head). Lateral Vertical Plane. It defines the center of the focal trough for the frontal teeth (incisors), i.e. the correct position of the carriage (backward or forward displacement of the rotating carriage) to have the teeth structures falling into the focal trough. The laser beams are activated with ALIGNMENT LIGHTS key on the control panel and stay on for 30 s. The laser aiming system is a Class I laser product. WARNING. Avoid unnecessary exposure of the eyes of the patient or of the operator to the laser radiation and pay attention that the laser beams are not intercepted by any optical device.

3.7

Resetting Carriage in Patient Entry Position

 The carriage is in “PATIENT ENTRY” position when the tube housing assembly is on the right. The laser lights can be switched on and the alignment of patient performed. In case of different position:  Push briefly the X-ray pushbutton or the ARM MOVEMENT the control panel to rotate forward.

key on

 Keep pressed the RETURN key until starts for backward rotation, from the READY position to PATIENT ENTRY position.

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3.8

Patient Positioning

 Remove from the patient any metal item such as provisional denture, earrings, necklaces, which might cause ghost images on the radiograph (side picture).  In case a protective apron is used leave the neck free not to interfere with the X-ray beam (radiation enters from sides and from rear of the patient).  With the carriage in “entry” position, place the patient facing the mirror and make sure he is holding firmly the handles.  The patient must stay with lowered shoulders with advanced feet (almost close to the column) to stretch the spine at cervical level for a better beam penetration.  Start with the unit slightly higher. Ask the patient to tilt the head backward and bite the reference block. Then press the DOWN key and lower the unit at the same time asking the patient to tilt the head forward following the lowering of the carriage. Stop when the Frankfurt plane is horizontal. Same procedure in case the chin rest is used. UP  Use the angled mirror to see the face of the patient KEY and correct any side rotation of the head.  Ask patient to open the lips and teeth are visible. By biting the thin block, mouth is closed and teeth are DOWN not superimposed. Use of cotton roll allows for same KEY condition is in case the chin rest is used instead.  Switch the positioning lights ON to properly locate the in-focus layer on frontal teeth by pressing the alignment lights key.  Correction of the side position of the carriage is not required for patients with normal occlusion  In case of patient with overjet for class II or class III malocclusion, using the the relevant displacement key left or right, the rotating carriage is shifted forward or backward until the lateral light beam falls over the canine (the corresponding shift in mm is displayed). In this position the roots of the frontal teeth are positioned into the in-focus layer. 111104

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FONA XPan – Operating Instructions  Ask the patient to swallow and keep the tongue lightly pressed to the palate, then recommend to stay calm and firm, avoiding movements, till the end of the exposure.

a) Correct position, Frankfurt plane is horizontal

b) Wrong position, head tilted forward, V shaped dental arch

c) Wrong position; head tilted backward, flat dental arch

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3.9

TMJ projections

 Two exposures are usually taken with closed (habitual occlusion) and open mouth.  The full set of 4 images is placed on one film. .    

2

4

3

1

Patient is positioned with bite block under the nose. The lateral light is set on canine as for standard panoramic. Once taken the first set of two images, return the unit. A second set of two exposures (open mouth) can be taken immediately.

3.10

Maxillary Sinuses

 Patient is positioned with bite block under the nose.  The lateral light is set on canine as for standard panoramic.

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3.11

Panoramic Exposure

 In case of digital panoramic imaging activate OrisWin Pan program on computer and start the procedure for a new image acquisition (File/New Image).  The operator is invited to stay behind the patient, three meters from the column, always keeping an eye to the patient, ready to terminate the exposure in case of need, at any time (section 2.2, Operation, at page 8).  Press the exposure hand-switch and hold it down during the whole cycle until the acoustical and optical alarms are terminated and the rotating carriage and the cassette holder stop.  Press the hand switch or the ARM MOVEMENT key. The rotating unit performs the first part of return function to make it easier for the patient to exit.  Remove the exposed cassette and process the film immediately (for analog systems only).  Press the hand switch or the ARM MOVEMENT key to return to the initial position for patient entry. Last used data are stored and appear on the display: Program number, patient size, carriage shift, used collimator, kV level, mA value.  Press the hand switch to have the rotating arm moving to the START position. In case the patient is not properly positioned, the rotating arm can be brought to the “entry” position by pressing for few second the ALARM RESET key.  Error messages to be handled by the operator:  11 - Exposure Aborted During Irradiation. The film in the cassette has to be changed to take a new radiograph, because exposed.  12 - Exposure Aborted Before Irradiation. The film in the cassette was not exposed and can be used for next rradiograph.  20 - Exposure aborted after irradiation. The film in the cassette was correctly exposed and can be processed.

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4.

CEPHALOMETRIC RADIOLOGY

4.1

Cephalometric Programs Icon

Program Latero-Lateral with soft tissue filter Antero Posterior or Postero-Anterior

Format Notes A1 for Adult A2 for Child S S

Wrist

4.2

Technique Factors

The X-ray tube current in the Ceph mode is automatically set to the value of 10 mA. The available mAs values are reported in the table below. 2 4 8 16 32 2.5 5 10 20 40 3.2 6.3 12 25 Values are reported in the tables below for film-screen combination of speed 400. In case of used of receptors with different sensitivity, the technique factors have to be changed accordingly.  Increase of technique factors lead to darker radiographs.  Decrease of technique factors lead to lighter radiographs. Ceph Exposures LL Adult LL Child AP Wrist Patient Size kV mAs kV mAs kV mAs kV mAs 12 70 12 70 12 61 5 1 Small 73 12 70 12 76 12 61 5 2 Medium 76 12 73 12 79 12 61 5 3 Large 79 12 73 12 82 12 61 5 4 Extra large 82 Values of kV and mAs are automatically set and indicated on the display upon selection of type of examination and patient size. In case a change is needed the relevant parameter can be corrected by acting on the keys on the control panel. The kV level is related to penetration of X-ray, i.e. the ability to go through the anatomical structures and build the image information: the bigger the patient the higher the kV level has to be.

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4.3

Collimator for Cephalometric

On Pan Ceph units 2 of the 6 collimator positions on the revolving disk are available for the panoramic projections of adult and child. Beam collimation for panoramic on Panoramic & Cephalometric Units Imaging Display Program Projection Size cm Standard panoramic and partial PAN A 1-3-4-5-6-7 15x30 views PAN B 2 12x24 Child panoramic 4 positions on the revolving disk are reserved for teleradiography in metric or inch formats as reported in the following. Film Unit - Ceph Metric Format Imaging Display Program Projection Size cm 18x24 S 9 - 10 18x24 Antero Posterior (vertical symmetric) Latero Lateral Adult 18x24 A1 8 18x24 (vertical asymm.) Latero Lateral Child 18x24 A2 8 18x24 (vertical asymm.) 24x30 S 9 - 10 24x30 Carpus (vertical symmetric) Film Unit - Ceph Inch Format Imaging Display Program Projection Size inch 8X10 S 9 - 10 8x10 Antero Posterior (vertical symmetric) Latero Lateral Adult (horiz. asymme10X8 A1 8 10x8 tric) Latero Lateral Child (horiz. asymme10X8 A2 8 10x8 tric) 10X10 S 9 - 10 10x10 Carpus (vertical symmetric)

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4.4

Film Formats and Cassette Placement

 Symmetric Format.  Patient is placed facing the X-ray generator.  Used for Antero-Posterior (AP, frontal) views and wrist.  Cassette is aligned on cassette holder with mark “S”.  Unit comes configured either for 18x24 cm or 8x10” format.  Asymmetric Format.  Patient is placed with the X-ray beam entering the left side.  Used for Latero-Lateral (LL, side) views.  Soft tissue filter A1 for adult or A2 for child.  Ear plugs are aligned to the X-ray beam direction.  Cassette is aligned on cassette holder with mark “A”.  Unit comes configured for 18x24 cm, 8x10”, or 10x10” format.

4.5

Cephalometric Exposure

 The operator is invited to stay in front of the column, three meters from it, always keeping an eye to the patient, ready to provide assistance in case of need, at any time(section 2.2, Operation, at page 8).  Press the exposure hand-switch and hold it down during the whole exposure time until the acoustical and optical alarms are terminated. The longest exposure tiem in ceph mode is of 4 seconds.  Remove the exposed cassette and process the film immediately.

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5. 5.1

MAINTENANCE Cleaning

WARNING. Always disconnect the system from the mains (main switch in the room) before cleaning it. Use a mild soap to remove fingerprints or other traces of dirt being careful not to let liquid substances penetrate the machine. The plastic covers can be cleaned with a soft cloth and a mild detergent.

5.2

Disinfection

The parts that come into contact with the patient must be cleaned after each use with a detergent (for example, a 2% ammonia solution) and then disinfected. DO NOT use solvents or corrosive substances. The bite block can be sterilized in autoclave at 121°C.

5.3

Technical maintenance

The user is responsible for keeping the system in normal efficiency conditions. Failure to observe the instructions relieves the manufacturer or his agent from any responsibility for injury, damage or non-conformities that may consequently occur. The integrity of every part of the machine and the fluidity of movements must be checked regularly by the user. WARNING. Any fault or malfunction must immediately be corrected by qualified and trained personnel. Any defective part that may compromise safe use of the machine must be repaired or replaced. Machine maintenance must be carried out at least once a year by qualified personnel according to indications provided by the manufacturer. The following activities must be carried out:  Complete check of system operation (kV, mA, s)  Check all the mechanical and electrical safety functions.

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Disposing of Obsolete Equipment

5.4

A radiological system is made of different materials which include many kinds of metals (iron, aluminum, lead, copper and others), plastic materials, electronic components and dielectric oil in the tank of the X-ray tube. The "crossed-out wheeled bin" symbol on the product indicates that the product at the end of its useful life must not be disposed of as unsorted municipal waste but has to be collected separately and delivered to specialized operators for recycling or disposal of waste of electrical and electronic equipment (WAEE), in compliance with existing laws. By doing in this way possible negative effects on human health and environment are prevented, and recycling of the component materials is promoted. Penalties are applicable to illicit disposal. FONA and its local Dealers commit to fulfill obligations related to the management of WAEE of professional nature, according to the provisions of the European directives 2002/96/EC and 2003/108/EC.

6.

CLASSIFICATION

FONA XPan /Ceph are classified as follows:  CE: the systems are listed in class IIb, with accessories in class I  FDA: Class II equipment, including Class I lasers.  IEC: Class I, type B equipment with Class I lasers (IEC 60825-1). FONA XPan /Ceph comply with the following standards. IEC 601-1 IEC 601-1-2 IEC 601-1-3

General requirements for safety Electromagnetic compatibility General requirements for radiation protection in diagnostic X-ray equipment EN 60601-1-4 Programmable Electrical Medical Systems IEC 601-2-7 Particular requirements for the safety of high voltage generators of diagnostic X-ray generators IEC 601-2-28 Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis 21CFR1020.30 Performance Standards for Ionizing Radiation Emitting Products: Diagnostic X-ray Systems and their major Components 21CFR1020.31 Performance Standards for Ionizing Radiation Emitting Products: Radiographic Equipment 21CFR1040.10 Performance Standard for Light Emitting Products: Laser products IEC 60825-1 Safety of laser products. Part 1: Equipment classification, requirements and user’s guide

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Appendix A Alarm Messages Warning Messages A B C D E Num 1 2 3 4 5 6 7 9 11 12 13 14 15 16 17 19 20 21 23 25 26 32

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Low Battery X-ray generator hot CAM init Adjust Arm Position Wait for PC ready Error Messages kV reference signal out of range mA reference signal out of range Carriage rotation encoder failure Carriage displacement encoder failure Carriage rotation sensor failure Carriage displacement sensor failure Cassette displacement sensor failure Tube-head temperature exceeding limit Exposure aborted during irradiation Exposure aborted before irradiation 38 V DC supply out of range 24 V DC supply out of range 15 V DC supply out of range 5 V DC supply out of range High voltage failure Exposure time exceeded Exposure aborted after irradiation No tube current Filament current out of range Thermal Sensor Failure Battery fault (low voltage) Control unit fault

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Appendix B Icons Compliance to European Community Requirements

Compliance to North American Safety Requirements

OFF (disconnected from mains supply)

See the Annexed Documentation

The unit is READY

ON (connected to mains supply)

X-ray indicator (ionizing radiation emission)

Radiation Emission Light

Radiography Push Button

Digital Detector indicator (green light)

Program selection panoramic and cephalometric

Program selected 1 through 7 for Pan, 8 through 10 for Ceph

USB Interface (orange light)

Patient size selection: small, medium, large extralarge

Standard panoramic

UP carriage movement

Increase parameter kV level mA or mAs level

Child Panoramic

DOWN Carriage movement

Decrease parameter kV level mA or mAs level

Half Panoramic Left

Fuse

Carriage shift right for patient positioning

Half Panoramic Right

Carriage shift left for patient positioning

Anterior Dentition

Protective Earth

Entity of carriage displacement in mm

TMJ Open and Closed Mouth

Inherent Filtration

Type of collimator selected (Pan, Child, AP, LLA, LLB, APXL)

Maxillary Sinus

Dispose properly Do not abandon in the environment

Arm Sequential Movement

Ceph Latero Lateral

Fragile, Handle With Care

Patient alignment laser beams (15 s ON)

Ceph Antero Posterior

Fear of Humidity

Test mode without radiation emission

Wrist

Up, Do Not Overturn

Alarm Reset

Size Adult/Child: small, medium, large extra-large

Stacking Limit Number

IEC Type B Equipment

The unit is ON

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Alternate Current

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Appendix C Technical Data EXTRAORAL RADIOGRAPHIC SYSTEM FDA Classification Class II (21CFR872-1800, 21CFR892.1650) IEC Classification: Class I, type B Power Supply: 230 V ± 10%, 50/60 Hz, 8 A, slow fuse 115 V ± 10%, 50/60 Hz, 16 A, slow fuse Mains Resistance: < 0.8 ohm at 230 V, < 0.4 ohm at 115 V X-ray generator: Multipulse at 40-80 kHz Anode Voltage: 61 - 85 kV ± 5%, constant potential Anode Current: 4 - 10 mA ± 10%, direct current (DC) Focus size: 0.5 IEC 336 Inherent Filtration > 3.0 mm Al @ 85 kV Leakage Radiation < 50 mR/h (0.43 mGy/h) @ 100 cm, 85 kV, 10 mA Column Heigth 220 cm/87” Maximum height 225 cm/88.7” Displacement 92 cm/36.2”, from 90 to 182 cm (35 to 71.7”) Vertical Movement Motorized displacement Patient Positioning Motorized horizontal displacement Centering Light 3 lasers: Lateral, Median sagittal, Frankfurt Centering Reference Bite block and chin rest for edentulous, tunable temporal resting bars (option) Source Image Distance Pan 51.3 cm/20.2”, Ceph 165 cm/65” Vertical Magnification Pan 27%, Ceph 10% Panoramic Projections: Adult standard with constant vertical magnification on dental arch(14 s), Child at reduced dose (13 s), Half Dentition Left (7 s), Half Dentition Right (7 s), Anterior Teeth (4.9 s), TMJ habitual occlusion or opened at maximum extent (3.5 s), Maxillary Sinuses (12 s) Ceph projections Antero Posterior, Latero Lateral Adult, Latero Lateral Child, Carpus Cool down pause: Variable pause depending on requested tube load Weight: Pan Solo 100 kg/220 lb, Pan Ceph 120 kg/264 lb LASER LIGHTS FDA Classification Class I Wavelength 650 nm Output Power < 0.11 mW at 100 mm

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Appendix D Labels

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Appendix E Cooling Curves COOLING CURVE OF X-RAY TUBE kJ 20 18 16 14 12 10 8 6 4 2 0 0

1

2

3

4

5

6

Time (min) COOLING CURVE OF TUBE HOUSING ASSEMBLY kJ 120 100 80 60 40 20 0 0

15

30

45

60

75

90

105

120

135

150

165

180

Time (min)

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Appendix F Fuse Table FU 303

230 V

115 V

F 501

T8A 5x20

T 16 A 6.3x32

FU 303

T 1.6 A 5x20

T 3.15 A 5x20

FU 304

F 6.3 A 5x20

F 6.3 A 5x20

FU 305

F 6.3 A 5x20

F 6.3 A 5x20

F MOT

T4A 5x20

T4A 5x20

CONFIGURATION CONNECTOR PLUG

FU 304

FU 305

POWER SUPPLY UNIT IS AT TOP OF VERTICAL CARRIAGE TO ACCESS REMOVE TOP PLASTIC COVER AND TOP METAL COVER

TOP PLASTIC COVER FIXED WITH 2 ALLEN SCREWS ON TOP 2 ALLEN SCREWS ON THE BACK TOP METAL COVER FIXED WITH 2 PHILLIPS SCREWS ON TOP

FUSE MOT IS ON THE LEFT SIDE BEHIND MIRROR PLASTIC COVER

FUSE F 501 IS ON THE RIGHT SIDE BEHIND MIRROR PLASTIC COVER

F 501

F MOT

MIRROR PLASTIC COVER IS FIXED WITH 4 ALLEN SCREWS ON THE BACK

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FONA Dental s.r.o. Stefanikova 7 SK-811 06 Bratislava, Slovakia www.fonadental.com