1 Introduction
6 Gendex Dental Systems
207723 rev 7
1.7.3 General warnings
Personnel operating the device must be adequately trained
with respect to the technological principles of operation and
radiation protection when using cone beam computed
tomography (CBCT) imaging.
This unit complies with the EMC (Electromagnetic
Compatibility) according to IEC 60601-1-2. Radio
transmitting equipment, cellular phones etc. shall not be
used in close proximity of the unit as they could influence
the performance of the unit.
Always ensure to fulfill the requirements of the local and na-
tional regulations.
The correct software and settings in the workstation are
essential to the performance of the unit. Consult technical
support to ensure correct setup.
Danger: Explosion hazard - do not use in the presence of
flammable anesthetics, gases or vapors.
The unit is factory set to operate using a 230-240 ±10 VAC
power supply. Never connect the unit to a power supply
different to the voltage marked on the unit.
If the unit needs to be connected to a multiple socket-outlet,
the socket shall not be placed on the floor.
To avoid the risk of electric shock, the unit must only be
connected to a supply mains with protective earth.
The site must fulfill the environmental requirements in the
installation manual chapter technical specifications.
There should be free space around the unit for safe
operation.
The PC / Ethernet switch to which the unit is connected,
should be approved appropriately (e.g. EN 60950, IEC
60950, UL 60950). After installation, check that the IEC
60601-1 leakage current levels are not exceeded.
This product itself complies with IEC 60601-1 medical
safety standard but in order to the system incorporating also
a PC to comply the standard, EITHER the PC has to be a
medical PC OR the PC has to be located over 1,5 meters
apart from the unit. The installer and the user of the system
shall confirm that at least one of the above requirements is
fulfilled. A PC is a medical one if it complies IEC 60601-1
standard and that is indicated in the accompanying
documents of the PC.
Approved: Laihonen Tuuli 2016-12-02 16:41
Reviewed: Nieminen Timo Antero 2016-12-02 15:31
Approved
See PDM system to determine the status of this document. Printed out: 2017-03-22 10:54:38
D507729, 7
Copyright © 2016 by PaloDEx Group Oy. All rights reserved.
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