
2 Introduction
2.10.3 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 national regulations.
The correct software and settings in the workstation are essential to the performance of
the unit. Consult technical support to ensure correct setup.
WARNING!
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.
The unit shall be connected directly to the acquisition PC with an Ethernet cable.
Connection through the LAN-network of the site is not allowed. Two network ports are
needed in the PC in order to connect also to the site network.
All service operations must be made by authorized service personnel only.
The annual service as described in manual is mandatory for the correct and safe
operation of the unit.
When taking exposures, operators and service personnel must protect themselves from
radiation and remain at least two meters (six feet) away from the unit during exposure.
Protect the patient from scattered radiation by placing a protective lead apron over the
patient.
The unit must be installed and serviced according to the unit Installation & adjustments
manual by a qualified technician.
Only personnel trained and approved by the manufacturer of the unit are allowed to
service the unit.
3D imaging should not be used for routine or screening examinations in which
a radiograph is taken regardless of the presence or absence of clinical signs and
symptoms. 3D imaging examinations must be justified for each patient to demonstrate
that the benefits outweigh the risks.
ORTHOPANTOMOGRAPH
™
OP 3D Pro
11
Содержание OP 3D Pro
Страница 1: ...ORTHOPANTOMOGRAPH OP 3D Pro User manual ENGLISH 216364 rev 6 0 805 5115...
Страница 2: ......
Страница 105: ...10 Technical data ORTHOPANTOMOGRAPH OP 3D Pro 105...
Страница 106: ...10 Technical data 106 ORTHOPANTOMOGRAPH OP 3D Pro...
Страница 114: ...10 Technical data 114 ORTHOPANTOMOGRAPH OP 3D Pro...