Fona XPan DG Plus Technical Manual

Technical Manuals

FONA XPan DG Plus_

English

Technical Manuals

2

ITALIANO

FONA XPan DG Plus

3

Table of contents

1. INSTALLATION INSTRUCTIONS ................................................................................................................... 6

1.1. DELIVERY CHECK LIST ........................................................................................................................... 7

1.1.1. Necessary Tools ................................................................................................................................ 10

1.2. GENERAL................................................................................................................................................ 10

1.2.1. System Components ......................................................................................................................... 11

1.2.2. Control panel (touchscreen) .............................................................................................................. 12

1.3. ROOM PREPARATION ........................................................................................................................... 13

1.4. HOST COMPUTER REQUIREMENTS ................................................................................................... 15

1.4.1. PC Workstation requirements ........................................................................................................... 15

1.4.2. System Software ............................................................................................................................... 15

1.5. POSSIBILITIES OF INSTALLATION ...................................................................................................... 16

1.6. HAND-SWITCH CONNECTION .............................................................................................................. 17

1.7. FACILITIES AND OPTIONAL.................................................................................................................. 18

1.8. ASSEMBLING THE SYSTEM ................................................................................................................. 19

1.8.1. Unpacking .......................................................................................................................................... 19

1.8.2. Preparing the column for wall mounting ............................................................................................ 22

1.8.3. Preparing the column for floor mounting (Optional) .......................................................................... 23

1.8.4. Mounting system body to the column ................................................................................................ 24

1.8.5. Lifting and securing the system ......................................................................................................... 26

1.8.6. Mounting the Cephalometric arm ...................................................................................................... 27

1.8.7. Removing safety bolts and transport bracket .................................................................................... 29

1.9. ELECTRICAL CONNECTIONS ............................................................................................................... 30

1.9.1. Configuring the power supply unit ..................................................................................................... 30

1.9.2. Connecting the motor for vertical movement .................................................................................... 31

1.9.3. Connecting the hand-switch and other facilities ................................................................................ 32

1.9.4. Connecting the remote hand-switch option ....................................................................................... 33

1.9.5. Connecting the external lights and door contact ............................................................................... 34

1.9.6. Connecting the system to the mains line .......................................................................................... 35

1.9.7. Connecting the column to protective earth ........................................................................................ 36

1.10. SYSTEM START-UP ............................................................................................................................... 37

1.10.1. Preparing the unit for test .................................................................................................................. 37

1.10.2. Performing system test without radiation .......................................................................................... 39

1.10.3. Tuning the side bearings on vertical travel ........................................................................................ 40

1.11. IMAGING SYSTEM ................................................................................................................................. 41

1.11.1. First connection of the device at the workstation .............................................................................. 41

1.11.2. Performing installation of software modules ..................................................................................... 43

1.12. X RAY TEST ............................................................................................................................................ 45

1.12.1. Taking a panoramic phantom radiograph ......................................................................................... 45

1.12.2. Taking a cephalometric radiograph ................................................................................................... 46

1.12.3. Degassing procedure ........................................................................................................................ 46

1.12.4. Checking power supply adequacy ..................................................................................................... 47

1.13. FINAL WORK .......................................................................................................................................... 48

1.13.1. Mounting the optional temple supports ............................................................................................. 48

1.13.2. Setting the unit for demostrations (when applicable) ........................................................................ 48

1.13.3. Putting covers back ........................................................................................................................... 49

1.13.4. Filling the installation report and warranty passport .......................................................................... 50

1.14. INSTALLATION REPORT ....................................................................................................................... 51

2. SERVICE INSTRUCTIONS ............................................................................................................................ 52

2.1. FUNCTIONAL DESCRIPTION ................................................................................................................ 53

2.1.1. Block diagram .................................................................................................................................... 53

2.1.2. PCB Displacement ............................................................................................................................ 54

2.1.3. Mains connection module .................................................................................................................. 55

2.1.4. Column motor driver board ................................................................................................................ 56

2.1.5. System fuses ..................................................................................................................................... 57

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2.1.6. Power supply unit ..............................................................................................................................58

2.1.7. Power switching unit JED 28 .............................................................................................................60

2.1.8. Control unit ........................................................................................................................................61

2.1.9. Multiplexer Board ...............................................................................................................................63

2.1.10. Ceph Interconnection Board ..............................................................................................................65

2.1.11. Network scheme ................................................................................................................................66

2.1.12. Modbus ..............................................................................................................................................67

2.1.13. Ethernet switch ..................................................................................................................................67

2.1.14. Detachable sensor .............................................................................................................................68

2.1.15. Tube-Housing assembly ....................................................................................................................69

2.2. SERVICE FUNCTIONS ...........................................................................................................................71

2.2.1. PAN Alignment ..................................................................................................................................71

2.2.1.1. Rotation Axis ......................................................................................................................................71

2.2.1.2. X Axis .................................................................................................................................................72

2.2.1.3. C Axis ................................................................................................................................................73

2.2.1.4. Rot. Dev. ............................................................................................................................................75

2.2.1.5. Coll. Dev. ...........................................................................................................................................76

2.2.2. Binning ...............................................................................................................................................76

2.2.3. ST Kv Filter ........................................................................................................................................77

2.2.4. Languages .........................................................................................................................................77

2.2.5. Ceph formats .....................................................................................................................................78

2.2.6. Tube head statistics ...........................................................................................................................78

2.2.7. Exposure setting ................................................................................................................................79

2.2.8. Battery change...................................................................................................................................80

2.2.9. Software info ......................................................................................................................................81

2.2.10. DAP setting ........................................................................................................................................82

2.2.11. Cam Offset .........................................................................................................................................83

2.2.12. Thermal setting ..................................................................................................................................83

2.2.12.1. Enable/Disable thermal control ..................................................................................................84

2.2.12.2. Thermal values editor.................................................................................................................84

2.2.13. Keyboard Test ...................................................................................................................................85

2.2.14. LEDS Test .........................................................................................................................................86

2.2.15. Automatic Test ...................................................................................................................................87

2.2.15.1. 100 PAN NO X-Ray ...................................................................................................................87

2.2.15.2. 10 PAN + X-ray ..........................................................................................................................87

2.2.16. X-Ray Test .........................................................................................................................................88

2.2.16.1. Continued X-Ray ........................................................................................................................88

2.2.16.2. Pulsed X-Ray .............................................................................................................................89

2.2.17. Encoders Test ....................................................................................................................................89

2.2.17.1. Rotation Axis ..............................................................................................................................89

2.2.17.2. Ceph Axis ...................................................................................................................................90

2.2.17.3. C Axis .........................................................................................................................................90

2.2.17.4. X Axis .........................................................................................................................................90

2.2.18. Voltages Test .....................................................................................................................................90

2.2.19. Ceph alignment..................................................................................................................................91

2.2.19.1. X and Rot Calib. .........................................................................................................................91

2.2.19.2. Sec. Collim. Slit ..........................................................................................................................92

2.2.19.3. CS Start Offset ...........................................................................................................................92

2.2.19.4. Ceph Axis Calib. .........................................................................................................................93

2.2.19.5. Coll. Offset .................................................................................................................................94

2.2.20. kV Mod Offset ....................................................................................................................................95

2.3. SERVICE PROCEDURES.......................................................................................................................96

2.3.1. Plastic covers .....................................................................................................................................96

2.3.2. Metal covers (Shields) .......................................................................................................................97

2.3.3. PCBs/Tube head replacement ..........................................................................................................98

FONA XPan DG Plus

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2.3.4. Filament calibration and Feedback signal calibration ....................................................................... 99

2.3.5. X-Ray Beam Alignment ................................................................................................................... 100

2.3.5.1. X-Ray Beam alignment – 2D Exams ............................................................................................... 100

2.3.5.2. X-Ray Beam alignment – CEPH Exams ......................................................................................... 102

2.3.5.3. Collimator alignment ........................................................................................................................ 107

2.3.6. X-Ray Beam Calibration .................................................................................................................. 108

2.3.6.1. X-Ray Beam calibration – 2D Exams .............................................................................................. 108

2.3.6.2. X-Ray Beam calibration – CEPH Exams......................................................................................... 116

2.3.7. Calibration files ................................................................................................................................ 116

2.3.8. Replacement of position sensors .................................................................................................... 117

2.4. SYSTEM MESSAGES ........................................................................................................................... 118

2.4.1. Warning Messages .......................................................................................................................... 118

2.4.2. Error messages ............................................................................................................................... 119

2.4.3. Other Alarms ................................................................................................................................... 122

2.5. ELECTRICAL SCHEMES ...................................................................................................................... 123

2.5.1. Mains connection module ................................................................................................................ 123

2.5.2. Dual Power Supply .......................................................................................................................... 124

2.5.3. Driver Motor Column ....................................................................................................................... 125

2.5.4. Power Switching Unit....................................................................................................................... 126

2.5.5. Control unit ...................................................................................................................................... 127

2.5.6. Multiplexer ....................................................................................................................................... 128

2.5.7. Ceph Interconnection Board ............................................................................................................ 129

3. MAINTENANCE INSTRUCTIONS ............................................................................................................... 130

3.1. VISUAL CHECK .................................................................................................................................... 131

3.2. KEYBOARD TEST ................................................................................................................................ 132

3.3. LIGHT AND SOUND INDICATORS ...................................................................................................... 133

3.4. PHANTOM RADIOGRAPH ................................................................................................................... 135

3.4.1. Panoramic Exams ........................................................................................................................... 135

3.4.2. Cephalometric Exams ..................................................................................................................... 136

3.5. AIMING LIGHTS .................................................................................................................................... 137

3.6. MECHANICAL MOVEMENTS VERIFICATION .................................................................................... 138

3.7. POWER SUPPLY ADEQUACY............................................................................................................. 138

3.8. ANODE VOLTAGE VERIFICATION ..................................................................................................... 139

3.9. ANODE CURRENT VERIFICATION ..................................................................................................... 141

3.10. CHECKING THE X-RAY BEAM ALIGNMENT ...................................................................................... 142

3.10.1. Panoramic Mode ............................................................................................................................. 142

3.10.2. Cephalometric Mode ....................................................................................................................... 143

3.11. INSPECTION CHECKLIST FORMS ..................................................................................................... 144

3.12. Forms ..................................................................................................................................................... 145

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1. INSTALLATION INSTRUCTIONS

ATTENTION

Interference with medical

devices by radio telephones

To guarantee the operational safety of medical devices, it is recommended

that the operation of mobile radio telephones in the medical practice or

hospital is prohibited.

ATTENTION

Laser light localizers used

This product incorporates Class 1 lasers as light localizers for the

positioning of the patient. They must not be used for other purposes. A

minimum distance of 100 mm must be maintained between the eye and

the laser. Avoid unnecessary exposure of the eyes and pay attention that

the beams are not intercepted by any optical device.

NEW SINCE

09.2018

MANUFACTURED BY

FONA S.r.l. Via Galilei 11 - 20090 Assago (MI), Italy

DISTRIBUTED BY

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

www.fonadental.com

FONA XPan DG Plus

7

1.1. DELIVERY CHECK LIST

Check list of system body box (120x80x86cm - 105kg)

1. System body

2. Cephalometric arm and assembly

3. Set of top covers

4. Mirror cover

5. Imaging Sensor

6. Handrest

7. Accessory box

8. Kit for remote hand switch (optional)

9. Temporal resting bar (optional)

Check list of accessory box

1. Chin rest and bite block kit

2. Assembly limit switches for column

3. Bite blocks (yellow and blue)

4. Nasal support for edentulous (yellow and blue)

5. Spare bolts and washers

6. Test phantom

7. Hand switch with cable

8. FONA Logostrip

9. Manuals

10. CD OrisWin DG Suite Software

11. CD with calibration files

12. Copper filter 0.5 mm (2 pieces)

13. USB Ethernet Adapter

14. CEPH Earplugs

Check list of optional kit for remote hand switch (optional)

1. Plastic box

2. Hand-switch

3. 10 m 4 wires cable

4. Coiled cable

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Check list of optional box temporal resting bar (optional)

1. Gear box with temporal bars

2. Mounting bolt (set of 2)

3. Resting bar tips (set of 4)

Check list of motorized column box (229x31x33cm - 42kg)

1. Motorized column

2. Bolts and washers for wall support

(set of two 8x20 with split washers)

3. Bolts and spacers for carriage holding PLATE

(set of 4 8x30)

4. Wall support

Check list of optional self-standing base (96x70x28cm - 38kg)

1. Self-standing base

2. Plastic cover

3. Mounting bolt 10x25 (set of 6)

4. Levelling screw (set of 4)

FONA XPan DG Plus

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Pictorial view of items in accessory box

1

Chin rest and bite block

kit

2

Assembly limit switches

for column

3

Bite block

3

Bite block for TMJ and

sinus exams

4

Nasal support for

edentulous

4

Nasal support for TMJ

and sinus exams

5

Spare bolts and washers

6

Test phantom

7

Hand switch with coiled

cable

8

FONA logostrip

9

Manuals

10

CD OrisWin DG Suite

Software

11

CD with calibration files

and sensor driver

12

Copper filter

0.5 mm

(set of 2)

13

USB Ethernet Adapter

14

CEPH Earplugs

(set of 2)

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1.1.1. Necessary Tools

In order to perform FONA XPan DG Plus system assembly and installation the following tools are required.

1

Flat head screwdriver, medium size and

small size

2

Phillips screwdriver, medium size and small

size

3

A pair of scissors

4

Open-end wrench

8 and 13 mm

5

Allen keys

2, 2.5, 3, 6, 8 mm

6

Electrical AC /DC multimeter,

10 VDC, 250 VAC, 1% accuracy or better,

complete with test leads with hooks or

alligator clips

7

Spirit level (max 20 cm)

8

Copper filter

size 4x8 cm, 0.5 mm thick

9

Technical needles test phantom

1.2. GENERAL

FONA XPan DG Plus

11

1.2.1. System Components

1

Column

7

Self-supporting base

2

Vertical Carriage

8

Up/down keys

3

CEPH Arm

9

X-Ray generator

4

Detachable Sensor

10

Control Panel (see next page)

5

Cephalostat

11

Rotating Arm

6

Bite support

12

Wall Support

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1.2.2. Control panel (touchscreen)

1

System ON and ready

8

PROGRAM Selection

2

X-ray emission

9

PATIENT build: small,

medium, large, extra large

3

ALARM or ERROR:

see Warning or Error

messages in the Service

Chapter

10

FORWARD Shift

(referred to patient)

BACKWARD Shift

(referred to patient)

4

INCREASE: kV(left),

mA(right)

11

BACK to patient entrance

position /Alarm Reset

DECREASE: kV(left),

mA(right)

12

X-ray Indicator

(Ionizing Radiation

Emission)

5

LIGHT beams:

LASER beams on (30 s)

13

X-RAY control button

6

RETURN

14

UP movement (on the sides

of the carriage)

7

TEST MODE

15

DOWN movement (on the

sides of the carriage)

FONA XPan DG Plus

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1.3. ROOM PREPARATION

Room layout

Room Survey

A visit to the installation site is recommended prior

to proceed to the installation to prepare the room.

Minimum room dimensions:

• PAN ONLY: 140x110x229 cm

• PAN CEPH: 240x110x229 cm

• The wall support at 210 cm from the floor.

• The self-supporting base needs to be

anchored to the floor with appropriate

screws.

Electrical issues

• The connection to the mains line has to be

intercepted by a safety switch to

disconnect the equipment from the mains

when needed.

• The connection to the mains line is

recommended to be made on the wall on

just on the left side of the column at about

80 cm (31”) from the floor.

• In case of need the exposure hand-switch

can be placed remotely using a 4 wire

cable (kit for remote mounting is available).

In this case, consider to set up for a cable

from external button to the point of

connection to the mains line on device.

• Cables for external lights to indicate X-ray

unit ON and X-ray radiation ON plus one

cable for door contact have to be prepared

if needed.

• Consider the possibility to have the

external lights cables in the wall exiting

close to the point of connection to the

mains line.

Radiation Protection

• The system is equipped with lead barriers

to cut residual radiation.

Shielding to the walls may be required

depending on local regulations.

Data Communication

• The connection to the computer for data

acquisition is made with a CAT 5e cable

supplied with the system.

Computer

• The computer to be compatible in relation

to hardware and software (operating

system) requirements and safety.

• It is recommended that the computer and

other additional devices for image

acquisition, processing, and printing

comply with the requirements of the safety

standard IEC EN 60601-1.

• If not, such hardware must stay outside the

patient area, i.e. at an horizontal distance

greater than 1.5 m from the patient or

more than 2.5 m from the floor, and it is

recommended that be compliant with the

requirements of the standard

IEC EN 60950.

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Overview of electrical connections in the room

FONA XPan DG Plus

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1.4. HOST COMPUTER REQUIREMENTS

The FONA XPan DG Plus system for panoramic radiology is connected

to the PC workstation with a CAT-5e cable connected to the PC via the

USB-Ethernet Adapter provided.

The PC workstation has to be devoted to radiographic imaging at top

priority. Local area network (LAN) connection is possible using the PC

network adapter.

The PC workstation is not part of the supply of the radiographic system

FONA XPan DG Plus and has to be procured separately.

1.4.1. PC Workstation requirements

The recommended system requirements for PC workstations are:

• Compatible operating system:

Windows 7 Professional / 8 / 10 (64 Bit)

• Memory: 4 GB RAM or higher

• CPU: Intel Core I5

• Hard Drive: 100 GB free disk space (storage requirements vary

depending on patient volume for each practice).

Recommendations for the PC workstation:

• to comply with the requirements of the standard IEC EN 60601-

1, if placed in the patient area

• to comply with the requirements of the standard IEC EN 60950,

if placed outside the patient area

Monitor display settings for dedicated workstation CRTs should be at

least 0.25 dot pitch @ 1024x768; for flat screen LCD screens 450:1

contrast ratio @ 1280x1024 resolution is recommended.

1.4.2. System Software

The system FONA XPan DG Plus requires the following software:

• Operating System: Windows 7 Professional / 8 / 10 (64 Bit)

• Imaging Software: OrisWin DG Suite for image acquisition,

processing and storage in the patient data base.

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1.5. POSSIBILITIES OF INSTALLATION

The unit can be installed in three ways according to the wall condition and material: unit installed with wall bracket

only, with self standing base only, in case the wall it is not suitable for fixation or wall bracket and self standing base

together, which is providing the maximum stability to the device.

The recommended bolt sizes are listed in the table below:

Diameter

Class

Core Section mm2

M 8X1.25

ISO 8.8

36.6

M 8X1

ISO 8.8

39.2

5/16” – 18 UNC

SAE- Grade 5

33.8

5/16’’ – 24 UNF

SAE- Grade 5

37.41

A Unit wall connected

The unit is connected to the wall with two bolts, using the wall bracket only.

WARNING Wall anchors! Each wall plug must withstand a pull of 500N (50kp

/111pounds). Depending on the construction of the wall, suitable special wall

anchors must be used or an anchor PLATE custom made.

INSUFFICIENT WALL OR HARDWARE STRENGHT MAY CAUSE THE

WALL HOLDER TO PULL OUT FROM THE WALL AND THE FULL

SYSTEM TO FALL ON PATIENT OR OPERATOR CAUSING

INJURIES.

B Use of self standing base

A self standing base is optionally available.

The self standing base must be secured to the floor with four anchors (pull

force normally on two back anchors).

WARNING Floor anchors! Each floor anchor must withstand a pull of 500N

(50kp /111pounds). Depending on the construction of the floor, suitable special

anchors must be obtained.

INSUFFICIENT FLOOR OR HARDWARE STRENGHT MAY CAUSE

THE SELF STANDING BASE TO PULL OUT FROM THE FLOOR AND

THE FULL SYSTEM TO FALL ON PATIENT OR OPERATOR CAUSING

INJURIES.

C Use of self standing base and additional wall bracket

The use of self standing base and wall bracket is providing maximum stability

to the system. The self standing base must be ordered separatelyas optional.

The self standing base must be secured to the floor with four anchors (pull

force normally on two back anchors).

WARNING Floor anchors! Each floor anchor must withstand a pull of 500N

(50kp /111pounds). Depending on the construction of the floor, suitable special

anchors must be used.

INSUFFICIENT FLOOR OR HARDWARE STRENGHT MAY CAUSE

THE SELF-STANDING BASE TO PULL OUT FROM THE FLOOR AND

THE FULL SYSTEM TO FALL ON PATIENT OR OPERATOR CAUSING

INJURIES.

FONA XPan DG Plus

17

1.6. HAND-SWITCH CONNECTION

The hand-switch can be installed in three different ways by following the local regulation of your County and the will of

the end-user.

A. Hand-switch on the unit in the treatment room

The unit is provided with hand-switch with coiled cable on the right side for use up to 3 m distance.

B. Hand-switch remote

A kit for mounting of the hand-switch remotely outside of

the X-ray room is optionally available.

The kit is provided with a 4 wire cable 10 m (39 in) long

and termination box with magnet for the hand-switch.

Kit for remote hand-switch

C. Hand-switch wall installed

The remote switch can also be a normal switch in series to

the door contact or instead of it, with a two wire

connection installed on a regular wall box as supplied

locally. Requirements according to local regulations.

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1.7. FACILITIES AND OPTIONAL

A Door contact and external lights

Safety connections are available in the mains connection module, behind the mirror cover (right side of the unit), for

the connection of the door contact and of the external warning lights (please refer to the paragraph Connecting the

external lights and door contact).

• A two-position block is available for the connection of a door contact to prevent X-ray radiation with door open.

• Open contacts for two external warning lights to be supplied at maximum of 250 VAC for the indication of:

• X-ray unit ON (when the unit is powered), two contacts on the right side of the four-position block

• X-ray radiation ON (during irradiation), two contacts on the left side of the four-position block

B Temporal resting bars

Temporal resting bars for use during patient positioning

are optionally available.

The device is mounted with two screws on the back of the

bite block /chin rest holder.

FONA XPan DG Plus

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1.8. ASSEMBLING THE SYSTEM

WARNING. Do not change the installation sequence. Follow the sequence as described.

1.8.1. Unpacking

The system comes in two boxes: System body box and column box.

Opening the system box

• Cut the adhesive tape sealing the carton box and open the flaps.

• Cut the protecting sack with scissors paying attention not to scratch

the internal items.

• Retrieve the packing list and check that listed items are received.

• Take the accessory box, open it, retrieve its packing list and verify that

all the listed items are received.

• Retrieve the Installation Manual to be used for system assembly and

installation.

WARNING. Avoid using the cutter

not to damage the internal items

1

Accessory Box

2

Cephalometric Arm

3

Optional Temple Support

4

Top Covers

Technical Manuals

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Open the column box

• Carton box: remove top cover using a screwdriver to open

• Keep top cover close to the box with foam blocks upward

• Retrieve the packing list and check that listed items are present.

• Cut the protecting sack with scissors paying attention not to scratch the external surface of the column.

ATTENTION.

Do not use a cutter to open the protecting sack not to damage the external surface of the column.

ATTENTION.

Heavy weight duty. Installation must be done by at least two operators.

NOTE: A small plastic bag containing the spacers, bolts and washers for column installation is found inside the

column box.

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Fona XPan DG Plus Technical Manual

Fona XPan DG Plus Technical Manual

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