FONA ART Plus C

Operating Instructions

English
 FONA ART Plus C Operating Instructions

Dear Customer Thank you for purchasing your new FONA ART Plus C X-ray unit for
panoramic and cephalometric radiography.
For this we have provided you with a set of technical literature:
Operating Instructions, Installation instructions, Maintenance
Instructions and Service Manual. Keep this literature for easy and
quick reference. In order to protect your warranty rights, please fill
out the “Installation Report” provided at the end of the installation
manual immediately after the 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 and Safety Notes.

Responsibilities of 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.

NEW SINCE: 08.2015

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

List of Contents

1. Warning and Safety Notes............................................................................................................... 3

2. Technical Description ...................................................................................................................... 5
3. Introduction ................................................................................................................................... 8
4. Operating Controls and Displays .................................................................................................... 10
5. Accessories .................................................................................................................................. 13
6. Application Software ..................................................................................................................... 14
7. Exposure programs....................................................................................................................... 20
8. Operation..................................................................................................................................... 24
9. Programming ............................................................................................................................... 34
10. Program Values ............................................................................................................................ 35
11. Care of the surfaces ..................................................................................................................... 35
12. Inspection and maintenance ......................................................................................................... 35
13. Error messages ............................................................................................................................ 36
14. Electromagnetic Compatibility ....................................................................................................... 38

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1. Warning and Safety Notes

Instructions The accompanying documents among which the Operating
Instructions and the Installation Instructions supplied with the unit are
integral parts of the product.
The original language of the Operating Instructions is English.
Labeling of warning In order to prevent injury to persons and damage to the equipment
and safety information you must also read the warning and safety notes given in these
Operating Instructions.
Destination of use This unit has been designed for use in creating panorama
radiographic exposures.
System assembly at installation The system is fully tested in manufacturing and can be operated once
the major modules are mechanically assembled at installation and
then connected to the power line.
General safety information As manufacturers of medical devices, we can assume responsibility for
safety-related performance of the equipment only if maintenance,
repair and modifications are carried out only by us or agencies we
have authorized for this purpose, and if components affecting safe
operation of the unit that may be needed are replaced with original
parts.
We suggest that you request a certificate showing the nature and
extent of the work performed, from those who carry out such work,
and specify that the certificate show any changes in rated parameters
or working ranges, as well as the date, the name of the firm, and a
signature.
For safety reasons only use original accessories indicated in this
Operating Instructions. It is the user's risk when using non-released
accessories.
Exposures of patients may only be taken if the unit functions fault-
free. Never leave the unit unattended.
Safety measures Following extreme temperature fluctuations, condensate formation
during switch-on may occur; therefore please do not switch on the device until normal
room temperature has been reached (see chapter 2, Technical
Description).
Electromagnetic Compatibility This unit may be operated in a residential/hospital area, provided it is
used under the responsibility of a trained medical operator, and
following the recommendations reported in chapter 14, .
Interference with medical devices by To guarantee the operational safety of medical devices, it is
radio telephones recommended that the operation of mobile radio telephones in the
medical practice or hospital is prohibited.
Malfunction of electronic units/ In order to prevent failure of electronic units and data storage
devices which are worn on the devices, e.g. radio-controlled watch and telephone card, etc., it is
patient's body essential that these be removed prior to X-ray exposure.
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.
Electrical safety 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.

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Computer hardware 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 that 1.5 m from the patient or more than
2.5 m from the floor, when placed above the patient, and it is
recommended that be compliant with the requirements of the
standard IEC EN 60950.
Mechanical safety 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 protection guidelines 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.
Observe the applicable health physics regulations. The radiation
protection facilities should be used.
DESIGNATED The operator should remain as far away from the X-ray tube as the
SIGNIFICANT ZONE
OF OCCUPANCY FOR cable of the release button permits (in the designated significant zone
THE OPERATOR of occupancy for the operator).
With the exception of the patient, no other persons may remain in the
room while the exposure is being made. Under exceptional
3m circumstances a third person, however not belonging to the dental
10 foot practice, may then assist.
Maintain visual contact with the patient and the unit during the
exposure and in case of faulty operation, immediately discontinue the
exposure by releasing the X-ray button.
Disassembly and reinstallation For disassembly and reinstallation of the unit proceed as described in
the installation instructions for new installation to ensure perfect
function of the unit and its stability.
Disposal It generally applies that any disposal of this product must comply with
the relevant national regulations. Please observe the regulations
applicable in your country.
Within the European Economic Community, Council Directive
2012/19/EU (WEEE) requires environmentally sound recycling/disposal
of electrical and electronic devices.
Your product is marked with the adjacent symbol. Disposal of your
product with domestic refuse is not compatible with the objectives of
environmentally 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 Directive
2012/19/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 lead lining and mineral oil.
Please contact your dealer if final disposal of your product is required.

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2. Technical Description
Equipment classification IEC: Class I, type B equipment
with Class I LASER sources (IEC 60825-1).
US FDA: Class II (21CFR872-1800, 21CFR892.1650)
with Class I LASER sources (21CFR PARTS 1040.10, 1040.11)
CE: medical device listed in class IIb

This product complies with the following standards:

IEC 601-1 General requirements for safety
IEC 601-1-2 Electromagnetic compatibility
IEC 601-1-3 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
IEC 60825-1 Safety of laser products. Part 1: Equipment classification, requirements
and user’s guide
US FDA 21CFR1020.30 Performance Standards for Ionizing Radiation Emitting Products:
Diagnostic X-ray Systems and their major Components
US FDA 21CFR1020.31 Performance Standards for Ionizing Radiation Emitting Products:
Radiographic Equipment
US FDA 21CFR1040.10 Performance Standard for Light Emitting Products:
Laser products
US FDA 21CFR1040.11 Performance Standard for Light Emitting Products:
Specific purpose laser products

CE mark This product meets the provisions of the European Council Directive
93/42/EEC relating to Medical Devices, and subsequent amendments
and integrations of which in the Directive 2007/47/EC of the European
Parliament and of the Council.

Nominal line voltage: 230 V ± 10%, 115 V ± 10%,

Nominal line frequency 50/60 Hz
Line fuse 8 A slow blow @ 230 V, 16 A slow blow @ 115 V
Mains Resistance ≤ 0.8 ohm at 230 V, ≤ 0.4 ohm at 115 V
Rating 1.8 kW

Curve form of high voltage High frequency multi-pulse, ripple ≤ 4%

Tube Voltage 61 - 85 kV ± 5%, constant potential
Tube Current 4 - 10 mA ± 10%, direct current (DC)
Focus size 0.5 IEC 336
Inherent Filtration > 3.0 mm Al @ 85 kV
Loading factor for leakage radiation 1.0 mA @ 85 kV
Leakage Radiation < 50 mR/h (0.43 mGy/h) @ 100 cm, 85 kV 10 mA
Cool down pause Variable pause depending on requested tube load
Maximum duty cycle 1/8

Column height 222 cm/87” (holes for wall plate at 210 cm/82.7” from floor)
Maximum height 229 cm/90.2”
Vertical displacement 89 cm/35”, da 90 a 179 cm (da 35.5” a 70.5”)
Vertical Movement Motorized control with slow and quick motion
Weight Pan Solo 100 kg/220 lb, Pan Ceph 120 kg/264 lb
Self standing base Optional on request. Order code 93 600 09000

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 FONA ART Plus C Operating Instructions

Panoramic Projections P1: Adult Standard Panorama: 14 s,

P2: Child Panorama: 13 s,
P3: Left hemi-arch: 7 s,
P4: Right hemi-arch: 7 s,
P5: Anterior Teeth: 4.9 s,
P6: TMJ normal occlusion or TMJ mouth opened: 2 x 2.2 s,
P7: Frontal View of Maxillary Sinuses: 12 s
Cephalometric projections P8: Antero-posterior (8 s),
P9: Latero-lateral (10 s),
P10: Carpus (8 s)
Anatomical Selection Patient build on 4 levels: Small, Medium, Large, Extra Large
kV setting 9 positions in 3 kV steps: 61, 64, 67, 70, 73, 76, 79, 82, 85 kV
mA setting 5 positions according to R10 scale: 4, 5, 6.3, 8, 10 mA
Source-Image Receptor distance Pan 51.3 cm/20.2”, Ceph 165 cm/65”
Vertical Magnification Panoramic: 27%
Cephalometric: 10%
Centering References Bite block, Chin Rest for edentulous
Accessories Temple support carbon fiber reinforced (optional).
Oder code 93 600 03060

Aiming lights
Type Class I LASER beam
Wavelength 650 nm
Output Power < 0.15 mW at 100 mm
Reference planes Lateral, Median Sagittal Vertical and Frankfort Horizontal planes
Pulse duration 60 s

Image receptor
Type Multi-element Cd(Zn)Te-CMOS
Active area 5.5 x 210 mm2
Effective pixel size 100 micron
Static resolution 5 lpp/mm
A/D conversion 16 bits
Computer interface Gigabit Ethernet connection
Resulting image format Panoramic image 15x30 cm, about 3000x1500 pixel
Cephalometric image 25x23 cm (8”x9”), about 2500x2400 pixel

Minimum requirements for PC

Standard Information Technology Equipment (ITE) certified
Operating System Windows XP SP3 or Windows 7 Professional (32/64 bits)
Recommended: Windows 7 Professional 64 bit
CPU Intel Core 2 Duo 3.0 GHz or higher. Recommended: Quad Core
RAM 4 GB minimum
Hard disk > 100 GB free disk space
Drives CD ROM, USB
PCI One PCI Express (PCIe) slot, full height
Display Adapter AGP or PCI Express connection or integrated non-PCI connected
Monitor 0.25 dot pitch; 450:1 contrast ratio
1024x768 minimum resolution; 1280x1024 recommended resolution

Environmental data
Operating conditions Temperature: from 10 to 40 °C
Humidity: from 30 to 75%
Pressure: from700 to 1060 hPa
Transport and storage Temperature: from –20 to +50 °C
Humidity: from 10 to 100%
Pressure: from 500 to 1060 hPa

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Cooling curve kJ 1 kJ = 0.741 kHU

X-ray tube

Time (min)
Cooling curve kJ 1 kJ = 0.741 kHU
Tube housing assembly 120

100

80

60

40

20

0
0 15 30 45 60 75 90 105 120 135 150 165 180
Time (min)

Used Icons
OFF (disconnected
Inherent Filtration
from mains supply)
ON (connected Fragile,
to mains supply) Handle With Care
Fuse Fear of Humidity

~ Alternate Current Up, Do Not Overturn

Stacking Limit
Protective Earth
Number

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3. Introduction
General Information FONA ART Plus C is a dental panoramic digital imaging system utilizing the
latest CdTe-CMOS technology. It offers exceptional image quality and
some advanced and unique features such as the ability to focus on
different focal troughs, for optimal diagnostic result in the day to day
routine.
The Operating Instructions and the Service and Installation Manual
provided with the system are an integral part of the product. The original
language of the Operating Instructions is English.

3.1 Destination of use

FONA ART Plus C is an extraoral dental X-ray machine for diagnostic use.
Any use different from what indicated has to be considered improper.
Panoramic dental X-rays are considered normal practice for a complete
examination of the dental arch (1), the maxillary area (2), the mandibular
area (3), and the temporomandibular joint (TMJ) area (4).

2
4 4

Models available  Panoramic Only (Pan Solo)

 Panoramic and Cephalometric (Pan Ceph)
Panoramic examinations  Panoramic on adult
 Panoramic on child with reduced dose
 Left-hand dental arch
 Right-hand dental arch
 Front dental arch
 TMJ in normal occlusion and in maximum opening
 View of the maxillary sinuses.
Cephalometric projections  Latero-lateral (LL) X-ray of the cranium with filter for soft tissues
 Antero-Posterior (AP) X-ray of the cranium
 Carpus (wrist).

3.2 General Description

The FONA ART Plus C system allows producing diagnostic images both in
panoramic and cephalometric mode by means of a digital image acquisition
module (digital sensor) that can be removed and positioned on a rotating arm
for panoramic acquisition or on a cephalostat for cephalometric acquisition
(tele-X-ray for cephalometry).
A gigabit ethernet connection cable allows interfacing with a computer for the
image acquisition, processing and storage operations using an image data base
program. The X-ray system detects where the digital sensor is connected thus
determining the operating mode: panoramic projections in PAN mode (PAN
side) or cephalometric projections in CEPH mode (CEPH side). If the digital
sensor is not connected to the system, it starts in standby mode.

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The main body of the X-ray system (refer to section 4 Operating

Controls and Displays) is composed of a vertical carriage (A) with a
rotating arm (C) to which are connected the power cable, the
connection cable to the computer, the hand-switch control with X-ray
control button (L), and the removable digital sensor (M).
The diagnostic equipment can be raised or lowered during patient
positioning with the up and down keys (K) to activate the motorized
DESIGNATED movement.
SIGNIFICANT ZONE
OF OCCUPANCY FOR The rotating arm (C) comprising a generator (D), a housing for the
THE OPERATOR PAN sensor (E) and a control panel (F) is connected to the vertical
carriage (A).
The column is fastened to the wall by means of a bracket (G).
3m Alternatively, an optional self-supporting base (H) is available to be
10 foot fastened on the floor.
The side arm with cephalostat (I) and a housing for the CEPH sensor
(J) is fastened to the load-bearing carriage (A).
The area designated for the operator is in front of the system 3
metres from the column.

The panoramic image of the dental arch is constructed with a thin

vertical X-ray beam that turns around the head of the patient from
the left to the right.
In order to be certain that the roots of the teeth, particularly incisors,
are within the layer in focus it may be necessary to adjust the
rotating arm forward or backward.
This is normally not necessary for patients with normal occlusion.
However, in cases of overjet with class II or III malocclusion, in
order to bring the roots within the layer in focus, you can correct the
O position of the rotating arm with the movement buttons (O) on the
control panel using the lateral light beam references.

The median-sagittal plane beam is used to control lateral rotation of

the head.
The Frankfurt plane beam is used to control forward or backward
tilting of the head.
To set the system to Tele-X-ray mode, position the digital sensor (M)
in the CEPH housing (J) after releasing it from the system by
pressing the release button (N) positioned at the top edge of the
digital sensor.
In addition, select the appropriate X-ray beam collimator by turning
the disc protruding from the lower part of the X-ray generator (P).
The Latero-lateral (LL) or Antero-posterior (AP) tele-X-ray image in
N O CEPH mode is constructed with a thin vertical X-ray beam that
horizontally scans the head of the patient.
In CEPH mode the Frankfurt plane light beam facilitates patient
P positioning for both LL and AP scanning.

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4. Operating Controls and Displays

4.1 System Components
G

J
E C

D
I
M
K

B L

A. Vertical Carriage
B. Column
C. Rotating arm
D. X-Ray generator
E. Housing for PAN Sensor
F. Control Panel
G. Wall Support
H. Self-supporting base
I. Cephalostat
J. Housing for CEPH sensor
K. Up/down keys
L. Hand switch
H M. Digital Sensor

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4.2 Control panel

Unit ON with light on display

READY green light ON when system ready

ALARM red light ON upon alarm message

EXPOSURE key on Hand Switch

X-ray Radiation – Yellow Light ON

PROGRAM Selection

INCREASE kV (left side) mA (right side)

DECREASE kV (left side) mA (right side)

PATIENT build: Small, Medium, Large, Extra-Large

LIGHT for alignment ON for 60 s

RETURN Arm Movement

TEST Mode without Radiation

BACK for backward movement and alarm reset

UP carriage movement

DOWN Carriage movement

BACKWORD Shift (referred to patient)

FORWORD Shift (referred to patient)

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4.3 Panoramic Operating Positions

A. PATIENT ENTRY position

Control panel and X-ray source on the right of the patient and
the image receiver on the left.

B. START position

System ready to start the exposure. When the unit reaches

the START position the green light of the READY indicator on
the control panel is turned ON

C. END position

At the end of the exposure the unit comes to a complete stop.

D. PATIENT EXIT position

Control panel and X-ray source on the left of the patient and
the image receiver on the right.

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5. Accessories
5.1 Rests and supports

Bite block Chin rest for edentulous patients

Nasal support for edentulous patients Bite block with chin rest

Temple support can be added as an option

Order code 93 600 03060

5.2 Service tool

Ball and needle phantom

Order code 7668010036

It is recommended to use only the accessories indicated in this Operating Instructions.

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6. Application Software
6.1 OrisWin DG Suite
This software manages the acquisition of the panoramic and
cephalometric X-ray images and also the associated patient data
records.
The images acquired with OrisWin DG Suite are saved in DICOM
format.
For more information on installation and use of the application, refer
to the OrisWin DG Suite user manual.
The installation and configuration operations are described in the
FONA ART Plus C service and installation manuals.
The image acquisition procedures are described below; the
instructions for subsequent processing and storage of the images
are described in the OrisWin DG Suite user manual.
NOTE. The USB software license must be connected to the PC,
or other PC in the local area network.

A. Starting
On the PC connected to FONA ART Plus C with OrisWin DG Suite
installed:

 Start OrisWin DG Suite and select the Patient module with the
relevant button

B. Selecting the patient

 Select the patient from the list or insert a new patient.
 Then start image management.

C. Selecting the X-ray system

 Start an acquisition session by selecting the Panoramic X-ray
system button.

The Ajat Application (sensor driver) will open.

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D. Image Acquisition
When the unit is ready for image acquisition, the green light is
turned on. At this point, the image can be acquired by pressing
the X-Ray button.

E. Preliminary Image Processing

Preliminary processing can be done immediately after image
acquisition.

 Grey level adjustment by moving the gamma cursor

Gamma cursor

 Focus can be activated in case of need.

Save changes and close the Ajat application. When finished, the
image is automatically saved in the patient data base.

F. Image Processing
The image can be further process using the OrisWin
environment.

Typical image processing sequence:

 LUT: Move the gamma value to obtain the desired darkness
 Sharpening: Click on “Filters”, and select “Tissue”  “Hard
Effect”
 Adjust the contrast with LUT  W/Level
 Use the “Area Filter” to correct specific areas
 Click on “Filters”, and select the “Magic Filter”

The above sequence is an example. For more details about the

processing tools, refer to the OrisWin DG Suite Reference Guide.

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6.2 Ajat Application Overview

A. File
Open image file Opens images saved as PNG,TIFF or DAT.
Open dataset Opens a saved dataset.
Reopen Lists the ten recent images for quick opening
Data repository Allows reopening of automatically saved images or dataset.
Save Image As Allows the saving of an acquired image.
The formats are
Tagged Image (TIF) 8 bit,
Tagged Image (TIF) 16 bit,
Portable Network,
Graphics (PNG) 8 bit,
Portable Network Graphics (PNG) 16 bit,
DICOM (DCM) 8 bit,
DICOM (DCM) 16 bit,
Binary 32 bit and Text (TXT).
Save Dataset As Allows you to save the full acquired data. The full dataset will be
several hundred megabytes and can only be viewed in this software.
Save image as TWAIN Returns an acquired image back to the software that called it.
(TWAIN mode only)
Close image Closes currently displayed image
Close dataset Finalizes dataset
Exit Closes the panoramic software
B. View
Show mean frame signal level Displays the average signal strength of the last exposure for support
purposes.
Show overview image Enables or disables the small overview window used while viewing
magnified images.
Show temperature plot Enables or disables the sensor temperature status windows.
Show function bar Enables or disables tools and status information displayed above the
image area.
C. Patient
Patient information Opens a dialog box for entering patient information.
Patient ID (up to 19 characters)
Family name (up to 43 characters)
Given names (up to 43 characters)
D. Image
Denoise Gaussian Noise removal tool
Denoise Median Smoothing tool
Sharpen unsharp mask Sharpening tool
Edge enhancement horizontal Sharpens horizontal edges
Edge enhancement vertical Sharpens vertical edges
Apply auto-leveling Automatically changes the grey levels to the best use of the display’s
dynamic range.
E. Tools
Settings Opens the advance setting area
Dataset Tools Advanced dataset handling tools
DICOM Opens the DICOM saving and sending options
Maintenance Sub menu that contains mechanical alignment, calibration,
diagnostics tools and open log file tool.
Send error report Can be configured to electronically send reports to support
personnel.

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F. Window
Tile horizontally Displays multiple open images side by side.

Tile horizontally Displays multiple open images side by side.

Tile vertically Displays multiple open images vertically stacked.

Tile square Displays multiple images in equal square pattern.

Cascade Displays multiple images as a cascade.

Dataset image Displays the current dataset on top of all open images.

G. Help
About Displays the software date and version.

H. Status Indicator (Traffic Light)

 Green: The sensor and software are ready to acquire and image.
 Yellow: The system is preparing to go to ready mode.
 Red: The system is not ready. See Troubleshooting.

I. Histogram
A histogram or graphical representation of how many times a colour occurs in an image. Use this tool to
adjust the brightness and intensity for the overall image. The histogram is adjusted using three sliding
arrows. The arrow to left represents the white end of the dynamic range and the arrow to the right, the black
end. The arrow in middle is used to shift the histogram toward the black or white (gamma correction). The
result of making a shift will be seen as brightening or darkening of the image. To change the contrast of an
image, black or white may be clipped by moving the far left and right arrows towards its opposite side.
Normally shifting the histogram is sufficient and the contrast can be left alone. Below are some examples of
shifting and clipping.

Histogram is shifted Histogram with white Histogram is shifted

toward the black clipped. toward the white

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J. Temperature
The optional temperature view is a real time report of the current
temperature of the sensor. This window can be toggled by selecting
View>Show temperature plot. By default this control is not enabled.

K. Tools
Magnifier Is a spot magnifier that is controlled by the mouse while the left
button is pressed. More magnification is available by right clicking on
the tool.
Move Tool is used to move the image when magnified beyond the limits of the
screen. When desired the entire image may be magnified by right
clicking anywhere on the image and select a desired magnification.
Use the move tool to navigate around the image. Optionally, a small
overview may be enabled for easier navigation while the image is
magnified. This feature is enabled by selecting View>Show overview
image.
Region Selection Tool Used for selecting a region of interest during focusing. Select a
starting position and click and hold the left mouse button. While still
holding the left button, move the mouse to enlarge the box to the
desired size.

Highlight Tool The highlight tool is used by moving the mouse while pressing the
left mouse button. This tool produces a high contrast filter, revealing
information in difficult regions. Right click the mouse button to
choose different sizes for the “High Light” square.

Move
Magnifier

Region Selection
High Light

L. Enhance
Image enhancement tools are provided for more advance diagnostics.
Denoising, Sharpening and Enhancing can be quickly applied to
improve quality, overcome anatomical defects or enhance areas of
interest.

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M. Focus
The focus area contains several advanced focusing tools. The area
selection tool is used to select an area of the image that is outside
the default focal trough and then the auto focus can be applied. The
manual focus or tilt tool may also be used for greater control

N. Colours
The colours section offers four different colour schemes as well as
invert.
These colours can be toggled on and off by left clicking the desired
colour.

O. User
This area is used configure and apply user defined image processing.
Many times you will find yourself using the same image enhancement
or other processing tools. To save time, the auto process button can
be configured to automatically apply any combination of tools
available in the image process area. Four additional configurable
tools are available, quickly configurable to any preference.

P. DICOM
DICOM options include, saving, printing and sending to a server.
Sending and printing require advanced configuration and must be
configured by an administrator. Save will automatically save an
image in the DICOM (DCM) format to a preconfigured location and
automatically name the image based on the patient information
provided.

Q. Undo
The Undo incrementally (once per click) removes image processing
that has been applied by the user utilizing the “Enhance” area.

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7. Exposure programs
7.1 Panoramic X-Ray Programs
To access the panoramic X-ray programs, connect the digital sensor in PAN position.
Symbol Program Exposure time
Standard panoramic on adult with constant vertical
14 s
enlargement on dental arch
Panoramic on child with reduced dose 13 s

Hemi left arch 7s

Hemi right arch 7s

Front teeth 4.9 s

Lateral TMJ in normal occlusion and maximum opening 2 x 2.2 s

Front view of maxillary sinuses 12 s

A. P1 Program: Standard Panoramic

Adult standard panorama The image at receptor’s plane is

with constant vertical magnification on dental arch: approximately 27% higher than real
 Program duration time approx.: 16 s size: the vertical magnification on adult
 Program exposure time: 14 s standard profile is 1.27:1 approximately.

B. P2 Program: Child Panoramic

Child panorama:
 Program duration time approx.: 16 s
 Program exposure time: 13 s

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C. P3 Program: Left Hemi- arch

Half Dentition Left:

 Program duration time approx.: 14 s
 Program exposure time: 7 s

D. P4 Program: Right Hemi-arch

Half Dentition Right:

 Program duration time approx.: 16 s
 Program exposure time: 7 s
E. P5 Program: Anterior Teeth

Anterior Teeth:
 Program duration time approx.: 14 s
 Program exposure time: 4.9 s

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 FONA ART Plus C Operating Instructions

F. P6 Program: TMJ
 Two exposures are usually taken with closed
and open mouth.
 Patient is positioned with bite block under
the nose.
 Once taken the first set of two images,
return the unit.
 A second set of two exposures can be taken
immediately.

TMJ closed mouth:

 Program duration time approx.: 16 s
 Program exposure time: 2.2 s

TMJ open mouth:

 Program duration time approx.: 16 s
 Program exposure time: 2.2 s

G. P7 Program: Sinus

Maxillary Sinuses:
 Program duration time approx.: 16 s
 Program exposure time: 12 s

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7.2 Cephalometric X-ray programs

To access the cephalometric tele-X-ray programs, connect the digital sensor in CEPH position.
Symbol Program Exposure time Format notes
A
Latero-lateral with filter for soft tissues 10 s
(asymmetrical)
Antero-posterior or S
8s
Postero-anterior (symmetrical)
S
Wrist 8s
(symmetrical)

A. P8 Program: B. P9 Program: C. P10 Program:

Latero-lateral Antero-posterior Carpus

Latero-lateral: Antero-posterior: Carpus:

Program duration time Program duration time approx.: Program duration time approx.:
approx.: 12 s 12 s 12 s
Program exposure time: 10 s Program exposure time: 8 s Program exposure time: 8 s

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 FONA ART Plus C Operating Instructions

8. Operation
8.1 Preparing for exposure
A. Switching ON the Unit
ATTENTION
Following extreme temperature fluctuations, condensate formation
may occur; therefore please do not switch on the device until normal
room temperature has been reached.

By pressing the mains switch in the lower part of the vertical carriage
under the mirror, the unit is supplied as indicated by the green light of
the mains switch.
Initialization  The system ON light on the control panel turns on
Please wait: xx  The display on the control panel turns on too
 System initialization is started
* Do Pan Reset *  Reset function has to be performed
61 6.3 ..
ATTENTION
When switching on the unit there must NOT be a patient positioned in
the unit. If a fault occurs which requires switching the unit off and
then back on again, the patient must be taken out of the unit at the
latest before switching it on again!
B. Reset Function
By pressing the RESET key the rotation arm locates the reference
points and moves to the PATIENT ENTRY position.
Depending on the specific condi
 “DO PAN RESET” if the system is waiting to execute alignment of
* Do Pan Reset * the mechanical axes when the digital sensor is connected for
61 6.3 .. panoramic projections in PAN mode.
 “DO CEPH INIT” if the system is waiting to execute alignment of
* Do Ceph Init * the mechanical axes including CEPH movement when the digital
61 6.3 .. sensor is connected for cephalometric projections in CEPH mode .
 “X-Ray Sensor Not Connected” if the digital sensor is not
X-Ray Sensor connected. To continue you need to connect the digital sensor on
Not Connected the PAN side or the CEPH side as described above. During sensor
connection, the sensor is reset and the progress is shown on the
control panel.

ATTENTION
If this message appears when the digital sensor is connected on the
PAN side or the CEPH side, check that the green light on the digital
sensor release button is on and that it is properly fitted in place,
otherwise push it into place on the holding magnet.

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C. Setting PAN or CEPH Mode

You can switch from PAN to CEPH mode or vice versa by moving the
digital sensor after releasing it by pressing the button at the top of
the sensor. This operation must be carried out with the system on in
order to allow the holding magnet to disengage and handling the
digital sensor with extreme care.
ATTENTION
Always grip the digital sensor with both hands during the discon-
nection and connection operations in order to prevent accidental
dropping which would irreparably damage it. In case of accidental fall
immediately contact Technical Service and do NOT use the sensor on
a patient before a functional test is performed.

01 0.0 PAN A The appropriate collimator will be automatically set through the
61 6.3 .. selection of the program.
kV mA mAs

D. TEST Mode without Radiation

With unit in START position, TEST mode can be activated to run the
unit without radiation. It is not necessary to connect the computer
nor enable the acquisition program
01 0.0 PAN A On the display:
-- TEST MODE --  The selected program number
 The message “Test Mode” instead of values of kV and mA
Starting the unit with the hand-switch allows for rotation of the arm
according to the program selected.
When the arm is returned to PATIENT ENTRY position test mode is
terminated and the units enters normal mode.
To exit TEST mode, press the TEST button again.
E. 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.

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 FONA ART Plus C Operating Instructions

8.2 Selecting exposure data

Select the exposure program with the key for PROGRAM selection

Select the PATIENT build, Small, Medium, Large, Extra Large

The selected program and the selected patient build are indicated by a
corresponding green light.
The pre-programmed technique factors, tube voltage in kV and tube
current in mA, are indicated on the display.
Manual correction of tube voltage and of tube current can be done using
the INCREASE or DECRESE keys at display sides
Upon manual correction of the pre-set technique factors, the corresponding
light on the patient build is turned OFF.
Setting tube voltage is done using the INCREASE or DECREASE keys at the
left of the display
The tube voltage can be set from 61 to 85 kV in steps of 3 kV.
61 64 67 70 73 76 79 82 85
Setting tube current is done using the INCREASE or DECREASE keys at the
right of the display. The tube current can be set from 4 to 10 mA.
4.0 5.0 6.3 8.0 10

NOTE. The pre-programmed values of technique factors are factory

programmed. Different values can be loaded if needed using the available
on board programming functionality. Refer to Service Manual for details.

F. Preparing the PC
NOTE. The USB software license must be connected to the PC, or other
PC in the local area network.
 Start the OrisWin Suite software and click on Patients.
 Select the “demo” patient from the list and start image management.
 Click on Panoramic module, which activates the device driver.
 When the unit is ready for image acquisition, the green light is turned on.

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8.3 Positioning the patient

A. PAN Patient Positioning
 Have the patient remove from head and neck all metallic
items such as removable denture, earrings, necklaces,
glasses which might cause ghost images on the
radiograph.
 Physical constitution, clothing, bandages, etc. must not
interfere with the movement of the arm.
If in doubt, perform a test rotation without radiation by
having selected before the TEST mode.
 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 back.
 Insert bite block or chin rest according need.

 With the arm in “PATIENT ENTRY” position, have the

patient stand in front of the mirror close to the unit.
 Bring the unit the proper height using UP or DOWN
keys.
NOTE
The height adjustment motor starts slowly and then
increases its speed. Press the height adjustment key until
the unit has reached the desired height.
 Bring the carriage to have the bite block or the chin rest
slightly higher.

… with bite block, and chin rest with bite block

 Have the patient bite into the indentation in the tip of

the bite block.
Mouth is closed but teeth are not superimposed.

… with chin rest, for patient without anterior teeth

 Make sure the upper and lower jaws are lined up with
each other.
Use of a cotton roll to prevent superimposition of teeth.

 The patient must stay with lowered shoulders and

advanced feet, close to the column, to favor spine
stretching at cervical level for a better beam penetration,
holding firmly the handles.
 Switch on the light beam localizers.
ATTENTION
The light beams are LASER lights. 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.

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 FONA ART Plus C Operating Instructions

 Turn on the LASER beams by pressing the LIGHT BEAMS button

 The FH horizontal beam should be falling between the upper edge of
the external auditory meatus and the lower edge of the infra-orbital
rim (Frankfort Horizontal plane FH).
 The height of the FH horizontal beam can be adjusted with a
dedicated knob.
 Adjust the height of the unit to have the Frankfort plane Horizontal
(FH) and the cervical vertebrae straight (not bent forward) and
stretched.
 Fine tune the head inclination for the FH setting by briefly touching
the UP or DOWN height adjustment key.
 Verify side rotation of the head with reference to the Midsagittal
light using the mirror from the back of the patient and correct in
case.
 Ask the patient to swallow and keep the tongue lightly pressed to
the palate.
 Eventually recommend to avoid movements till the end of the
exposure.
Correct position:
Frankfort plane is horizontal.

Wrong position:
Frankfort plane is NOT horizontal
The head is tilted forward thus
resulting in a V shaped dental arch.

Wrong position:
Frankfort plane is NOT horizontal
The head is tilted backward, thus
resulting in a flat dental arch.

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The lateral light beam does not need to be corrected for patients with
normal occlusion.
In cases of overjet with class II or III malocclusion, move the carriage
with the FORWARD/BACKWARD buttons until the lateral light beam is on
the canine, to have the roots of the incisors within the layer in focus (the
movement in mm is shown on the control panel) (13).

 Layer correctly centered

 The light beam (broken line) falls on the canine.
 The roots of the incisors fall exactly in the centre of the layer in
focus.
 The front teeth appear sharp.
 The light beam (broken line) falls behind the canine (dotted line).
 The roots of the incisors fall outside the layer in focus.
 The front teeth appear blurred and proportionally smaller.
LIGHT BEAM  Move the rotating arm forward (towards the column) to correct.

 The light beam (broken line) falls in front of the canine (dotted line).
LIGHT BEAM  The roots of the incisors fall outside the layer in focus.
 The front teeth appear blurred and proportionally larger.
 Move the rotating arm backward (away from the column) to
correct.

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 FONA ART Plus C Operating Instructions

B. CEPH Patient Positioning

A craniostat with auricular rods is available for Latero-lateral or
Antero-posterior projection and an adjustable nasion support.

Remove the nasion support by acting on the release pin in the case of
Antero-posterior or Carpus projection

NASION RELEASE
PIN

For the Carpus examination a transparent support is supplied with an

X-ray range outline to be fitted with two screws.

ATTENTION
Only use the accessories indicated in this Operating Instructions
CARPUS
SUPPORT
SCREWS

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8.4 Panoramic Exposure

ATTENTION
Operator: observe the radiation protection guidelines
(see chapter 1, Warning and Safety Notes).
Before releasing the exposure always check display for proper
exposure data for the patient.
Press the RETURN key or the EXPOSURE key on the hand switch for
short time to bring the arm from position PATIENT ENTRY to position
START, ready to start the exposure.
When the unit reaches the START position the green light of the
READY indicator on the control panel is turned ON
READY GREEN LIGHT ON

ATTENTION
Should you need to reposition the patient, the arm has to be moved
from the START position back to the PATIENT ENTRY position keeping
pressed the BACK key: see Resetting Carriage in PATIENT ENTRY
position, in the following.
Set the desired technical parameters in the X-ray system
Position the patient according to the selected PAN program
When the unit is ready for image acquisition, the green light is turned
Start the acquisition on.
program on computer

Go to the area designated for the operator behind the patient three
meters away from the column, or exit the room always keeping an eye
on the patient, ready to immediately interrupt radiation if necessary.
Expose the patient The exposure is released by keeping the exposure key pressed till end
of movement.
The rotation movement runs automatically in accordance with the
exposure program selected.
During radiation A yellow light is on control panel and on the exposure switch emitted
during irradiation and an acoustic signal is activated.

Exposure interruption
ATTENTION
ERROR
MESSAGE For safety reasons the operator can terminate the exposure any time
by releasing the exposure switch. Premature termination is signaled by
an error message (see details in the following).
After the exposure has been completed, acknowledge image
acquisition on computer.

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 FONA ART Plus C Operating Instructions

After the exposure At the end of the exposure the unit comes to a complete stop. Move
the arm to PATIENT EXIT position using the RETURN Arm Movement
key or the EXPOSURE key on the hand switch for short time.
Patient out Open the temple support (optional) and have the patient stepping out.
Arm back to patient entry position Move the arm to PATIENT ENTRY position for next exposure using the
RETURN key or the EXPOSURE key on the hand switch for short time.

P1 DA 123 mGycm2 The value of the dose by area (DA) product in mGy cm2 is indicated
67 6.3 on display after a panoramic exposure. Do acknowledge the Dose
Area value with RETURN or EXPOSURE key to proceed.
DA computations can be enabled or disabled via service function.

8.5 TMJ X-Ray

Normally two exposures are done for the temporomandibular joint
(TMJ), one in normal occlusion and one in maximum opening
The acquisition program composes the two exposures into one image:
the first viewed from the outside the second from the inside

2 4 3 1
 To position the patient use the bite block positioning it above the
upper lip just below the nose.
 The lateral light beam falls on the canine as with the standard
panoramic X-ray.
 Set the TMJ PAN examination in the image acquisition program on
the computer.
 Once the patient has been positioned and the X-ray system set to
READY position to start the examination, press “Start acquisition”
on the PC then start exposure by pressing the command button.
 After taking the first sequence, move the rotating arm to the initial
position. The second sequence can be taken without having to
wait for any significant time.
 After positioning the patient for the second exposure, set the X-
ray system to the READY position to start the examination, press
“Start acquisition” on the PC then start exposure by pressing the
command button

8.6 Maxillary Sinus X-Ray

 To position the patient use the bite block positioning it above the
upper lip just below the nose
 The lateral light beam falls on the canine as with the standard
panoramic X-ray
 Then continue as described in section 8.4 Panoramic Exposure.

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8.7 Cephalometric Exposure

Press the RETURN key or the EXPOSURE key on the hand switch for
short time to bring the arm from position PATIENT ENTRY to position
START, ready to start the exposure.
When the unit reaches the START position the green light of the READY
indicator on the control panel is turned ON.
READY GREEN LIGHT ON
Set the desired technical parameters in the X-ray system
Position the patient according to the selected CEPH program
Start the acquisition program on computer
Expose the patient The exposure is released by keeping the exposure key pressed till end
of movement.
After the exposure has been completed, acknowledge image acquisition
on computer.

8.8 Exposure Interruption

ATTENTION
For safety reasons the operator can terminate the exposure any time
by releasing the exposure switch.
Premature termination is signaled by an error message:
ERROR Error 11: Exposure aborted during irradiation.
#: 11 The patient has been partially exposed. Part of the radiograph is being
available. Examination may have to be repeated.
ERROR Error 12: Exposure aborted before irradiation.
#: 12 The patient was not irradiated.
Examination to be restarted.
ERROR Error 20: Exposure aborted after irradiation.
#: 20 No need to repeat the examination.

Wait PC READY Data Acquisition System Not Ready.

The data acquisition program has to be started first to make sure data
acquisition will be performed during radiographic exposure.
Automatic Exposure Blockage This feature protects the X-ray tube by preventing premature
triggering of a new exposure should the load requested by the next
exposure exceed the available capacity.
The red light on the control panel keeps blinking until cool-off time
ALARM RED LIGHT BLINKING
has elapsed.
Other error messages Possible malfunctions during the use generate an error message and
the unit is blocked. A list of messages are reported in chapter
Depending on the malfunction technical service might be required.

8.9 Remote hand-switch

The hand switch can alternatively be mounted remotely in case the
unit is located in an X-ray room which has a door and enables visual
contact with the patient.

An optional kit is available for remote mounting of the hand switch.

Order code 93 190 00155.

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 FONA ART Plus C Operating Instructions

9. Programming
Programming procedure In the factory kV and mA values are assigned to PAN and CEPH programs
for each one of the four types of patient build.
Such values can be re-loaded using a dedicated service function.
 Increasing the values results in greater blackening.
 Decreasing the values results in lesser blackening.
The kV level relates to the X-ray penetration characteristics, i.e. their
capability of going through the anatomical structures and forming the
diagnostic image: the larger the patient’s build the higher the kV level
(anode voltage) to be used.

9.1 Entering Service Mode

By keeping pressed the BACK key for 5 s the system enters Service Mode

Service function can be selected using the INCREASE or DECRESE keys on

Service +/- the RIGHT side of the display.
Expos. Settings
Scroll the menu until Exposure Settings is displayed

Press the PROGRAM key to enter Exposure Settings.

NOTE
Keep pressed the TEST key to reset all values to default (factory)
conditions
By pressing the PROGRAM key select the exposure program

By pressing the PATIENT key select the patient build,

Small, Medium, Large, Extra Large

* SET kV / mA * Change the kV level to the desired value by pressing the

67 6.3 INCREASE or DECRESE keys at the LEFT side of the display

Change the mA level to the desired value by pressing the

INCREASE or DECRESE keys at the RIGHT side of the display
Keep pressed the LIGHT key to store the selected value

Repeat kV setting and mA setting

for the other types of patient build if requested
for the other CHILD or ADULT group of programs if requested
Press BACK key to exit EXPOSURE SETTINGS

Press TEST Mode key to exit SERVICE MODE

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10. Program Values

Factory programmed values Freely programmed values

PAN Programs

P1, P3, P4, P5, P6, P7 61/6.3 67/6.3 73/6.3 79/6.3

P2 61/5.0 67/5.0 73/5.0 79/5.0

CEPH Program

P8, P9 73/8.0 76/8.0 79/8.0 82/8.0

P10 61/4.0 61/4.0 61/4.0 61/4.0

11. Care of the surfaces

ATTENTION
Always disconnect the system from the mains (main switch in the
room) before cleaning it.
Cleaning 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.
Disinfecting 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 and the chin rest can be sterilized in autoclave at
134°C.

12. Inspection and maintenance

Inspection and maintenance work must be performed at regular
intervals to protect the safety and health of patients, users and third
parties.
Annual inspection performed by the As the operator, you should ensure the safety and reliability of your
operator or other authorized system by performing maintenance on it at regular intervals (at least
personnel once annually) or having this work performed by your dental
dealership.
Maintenance performed by the In addition to the scheduled annual inspection by the user or persons
service technician contracted to perform this, a maintenance inspection must be
performed by the service technician after 4, 7, 10 years and then
every two years.
Checking image quality At regular intervals, however at least once a year, the user must
evaluate the image quality.

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 FONA ART Plus C Operating Instructions

13. Error messages

13.1 Warning messages
# Message Action required
A Low Battery (NVRAM battery) The battery on the control board is almost discharged and
must be replaced within a month.
B X Ray generator hot The system is cooling down and the requested exposure
would exceed the loading capacity. Wait until ready.
C CAM init (starting in progress) Wait for system to complete initialization.
D Adj Arm Position The rotating arm is out of position. Turn the system OFF
and manually relocate the arm centrally, then turn the
system ON.
E Wait PC ready The communication line to the computer is missing or the
image acquisition program is not in input mode. Perform
necessary correction. This warning message is not active
in test mode (service functions).
F X-Ray Sensor Not Connected If FONA XPan DG Plus does not detect the presence of the
X-ray sensor in either of the two positions (PAN or CEPH),
the message “X-Ray Sensor Not Connected” will be shown
on the display.
In this condition, FONA XPan DG Plus will remain in
standby until it detects the presence in one of the two
positions.
If the digital sensor is installed but not detected, an
electrical problem may have occurred.
A manual sensor release function is available in the event
that it is locked by the holding magnet. The release
procedure must be carried out by appropriately trained
persons.
G Wrong CEPH Format The message “Wrong CEPH Format” appears when there
is an incongruence between the configuration of the dip
switches in the control unit and the CEPH format selected
with the CEPH Format function in the Service menu.
The message is shown once the examination start position
in CEPH mode has been reached

13.2 Error messages

The ERROR number is shown on the display with the red
light blinking.
ALARM RED LIGHT BLINKING
To reset the error condition, press the BACK key.

# Message Action required

01 kV reference signal Switch the unit off. Report to technical service.
out of range
02 mA reference signal Switch the unit off. Report to technical service.
out of range
03 Rotation sensor malfunction (R-axis) Switch the unit off. Report to technical service.
04 Translation sensor malfunction (X-axis) Switch the unit off. Report to technical service.
05 Rotation sensor reading error (R-axis) Switch the unit off. Report to technical service.
06 Translation sensor reading error (X-axis) Switch the unit off. Report to technical service.
09 Tube-head temperature exceeding limit Wait for tube cool down
11 Interruption of exposure during irradiation Restart if termination was requested by the operator.
Call for technical service if termination was spontaneous.

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12 Interruption of exposure before irradiation Restart if termination was requested by the operator.
Call for technical service if termination was spontaneous.
13 38 VDC supply voltage Switch the unit off. Report to technical service.
out of range
14 24 VDC supply voltage Switch the unit off. Report to technical service.
out of range
15 15 VDC supply voltage Switch the unit off. Report to technical service.
out of range
16 5 VDC supply voltage Switch the unit off. Report to technical service.
out of range
17 High voltage failure Switch the unit off. Report to technical service.
19 Set exposure time exceeded Switch the unit off. Report to technical service.
20 Interruption of exposure Call for technical service if termination was spontaneous.
after irradiation
21 Anode current insufficient Switch the unit off. Report to technical service.
or absent
23 Filament current out of range Switch the unit off. Report to technical service.
25 Thermal sensor faulty Switch the unit off. Report to technical service.
or not connected
26 System battery voltage below threshold Switch the unit off. Report to technical service.
27 Multiplexer board malfunction with sensor Switch the unit off. Report to technical service.
presence in PAN and CEPH
28 CEPH movement end stop exceeded Switch the unit off. Report to technical service.
30 CEPH movement end stop during Switch the unit off. Report to technical service.
examination
32 Microprocessor-controlled board fault Switch the unit off. Report to technical service.

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 FONA ART Plus C Operating Instructions

14. Electromagnetic Compatibility

14.1 Electromagnetic emission
The FONA ART Plus C system is intended for use in the electromagnetic environment specified below. The
customer or the user of the FONA ART Plus C system should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment
The FONA ART Plus C system uses RF energy only for its internal
Group 1 functions. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
The FONA ART Plus C system must be used only in a radio-
RF emissions
frequency shielded environment with a minimum shielding
CISPR 11
effectiveness.
Class B
FONA ART Plus C may be installed in environments with anti-X-ray
shielding with attenuation of at least 12 dB for radio interference
from 30 to 1000 MHz. (Class B+12).

14.2 Electromagnetic immunity

The FONA ART Plus C system is intended for use in the electromagnetic environment specified below. The
customer or the user of the FONA ART Plus C system should assure that it is used in such an environment.
Immunity test EN 60601-1-2 test Compliance level Electromagnetic
level environment
Electrostatic discharge (ESD) 6 kV contact
Residential /hospital
EN 6 1000-4-2 8 kV air EN 60601-1-2 test level
2 kV for power supply
Electrical fast transients/bursts lines
Residential /hospital
EN 6 1000-4-4 1 kV for input/output EN 60601-1-2 test level
lines > 3 m
Surges 1 kV differential mode,
Residential /hospital
EN 61000 4-5 2 kV common mode EN 60601-1-2 test level
Voltage dips, short interruptions 0% UT for 0.5 cycle
and voltage variations on power 40% UT for 5 cycles
Residential /hospital
supply input lines 70% UT for 25 cycles EN 60601-1-2 test level
EN 6 1000-4-11 0% UT for 5 sec

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14.3 Systems that are non-life-supporting

The FONA ART Plus C system is intended for use in the electromagnetic environment specified below. The
customer or the user of the FONA ART Plus C system should assure that it is used in such an environment.
Immunity test EN 60601-1-2 Compliance level Electromagnetic environment
test level
Portable and mobile RF communications equipment
should be used no closer to any part of the FONA ART
Plus C system, including cables, than the
recommended separation distances calculated from the
equation applicable to the frequency of the transmitter.

Recommended separation distances (d)

Radiated RF 3 V/m: 80 MHz 3 V/m d = 1.2 x √P
EN 61000-4-3 to 2.5GHz 80 MHz to 800 MHz
d = 2.3 x √P
800 MHz to 2.5GHz
3V
Conducted RF
150 kHz 3V d = 1.2 x √P
EN 61000-4-6
to 80MHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment

marked with the following symbol:

14.4 Recommended safety distances for systems that are not life-
supporting
The FONA ART Plus C system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the FONA ART Plus C system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the FONA ART Plus C system as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of the transmitter (m)
Rated maximum output of 150 KHz 80 MHz 800 MHz
transmitter (W) to 80 MHz to 800 MHz to 2.5GHz
d = 1.2 x √P d = 1.2 x √P d = 2.3 x √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection of structures, objects and people.

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 We reserve the right to make any alterations which may be required due to clinical improvements

FONA ART Plus C Operating Instructions – English Edition 150831

*6968235110*
FONA Dental s.r.o.
Stefanikova 7 SK-811 06
Bratislava, Slovakia
www.fonadental.com