Fona XDG - Introduction to FONA XDG; Installer Obligations for FONA XDG; Safety Warnings for FONA XDG Usage

FONA XDG – Service & Installation Manual
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1. INTRODUCTION
1.1 Purpose
The FONA XDG X-ray Equipment is designed to fulfil the needs for high resolution intra-oral radiography in
the general dental practice. The systems can be configured for wall, mobile solutions.
The Operator’s Manual and the Service and Installation Manuals supplied with the system are integral part
of the product. The original language of the Operator’s Manual is English.
1.2 Equipment Classification
 IEC: FONA XDG is a Class I, type B equipment
 FDA: FONA XDG is a Class II medical device equipment (21 CFR 872-1800).
1.3 Applicable Standards
The FONA XDG system configurations comply 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
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
21 CFR 1020.30
Diagnostic x-ray systems and their major components
21 CFR 1020.31
Radiographic equipment
93/42/EEC
European Directive concerning medical devices (1993)
1.4 Environmental Data
Applicable ranges of temperature, humidity, and atmospheric pressure are reported here below both for
operation and transport conditions.
Ambient
Transport & Storage
Temperature
from 10 to 40 °C
from –20 to +50 °C
Relative Humidity
from 30 to 75%
10 to 90%
Pressure
from 700 to 1060 hPa
from 500 to 1060 hPa
1.5 Obligations of the Installer
Obligations of the Installer are:
 To make sure that the line voltage specified by the Manufacturer of the equipment is available
and within the specified range.
 For safety reasons verify that a proper switch is available to disconnect from line voltage supply when
needed during installation.
 Install and test the equipment with due diligence according to the installation instructions from the
Manufacturer.
 To provide the Operating Instructions to the User.
1.6 Warning
Use the system only after proper assembly and installation as per manufacturer’s instructions.
X-ray equipment produce ionizing radiation that may be harmful if not properly controlled. It is therefore
recommended that the equipment be operated by trained personnel only in accordance with existing law.
Even if compliant to specifications of electromagnetic compatibility, it is recommended not to use the
equipment in presence of external electromagnetic fields, such as those generated by cellular phones,
which might interfere with the electronic circuits of the system.
1.7 Demonstration
In order to use of the system for demonstration purposes radiation emission has to be inhibited by
disconnecting the supply cables to the X-ray head into the wall adaptor or into the timer.
Cables to be disconnected are those leaving the connection block towards the X-ray head (“out”).
Make sure that the disconnected cables are properly insulated to prevent undesired contacts with live
points. This task has to be done by trained personnel only to avoid the risk of electrical shock.