PRE-INSTALLATION INFORMATION
2 Planmeca ProOne
Installation Manual
2 PRE-INSTALLATION INFORMATION
WARNING
DO NOT CONNECT ITEMS WHICH ARE NOT SPECIFIED AS
PART OF THE SYSTEM.
WARNING
THE X-RAY UNIT MUST BE CONNECTED TO A DEDICATED,
PROTECTIVELY GROUNDED POWER LINE (NO OTHER DEVICES
ARE CONNECTED TO THE SAME POWER LINE).
WARNING
DO NOT CONNECT A MULTIPLE PORTABLE SOCKET OUTLET
(MPSO) OR EXTENSION CORD TO THE SYSTEM.
NOTE The PC connected to the system must be:
- approved by local authorities: e.g. IEC-approved (CE marked), UL/CSA approved
- located outside the patient area (more than 2m (79 in.) from the X-ray unit) and
- protectively grounded.
NOTE External equipment intended for connection to signal input, signal output or other
connectors, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical equipment). In addition, all such
combinations - systems - shall comply with the standard IEC 60601-1-1, Safety
requirements for medical electrical systems. Equipment not complying to IEC 60601
shall be kept outside the patient area (more than 2m (79 in.) from the X-ray unit).
Any person who connects external equipment to signal input, signal output or other
connectors has formed a system and is therefore responsible for the system to
comply with the requirements of IEC 60601-1-1.
NOTE EMC requirements have to be considered, and the equipment must be installed and
put into service according to the specific EMC information provided in the Technical
manual, section “EMC INFORMATION”.
NOTE Portable and mobile RF communications equipment can affect the Planmeca ProOne
X-ray unit. For minimum distance between portable and mobile RF communications
equipment and the Planmeca ProOne X-ray unit, see Technical manual, section “EMC
INFORMATION”.
NOTE Never place or hang any objects on any part of the X-ray unit.
NOTE Make sure that you cannot get caught or hooked up on any part of the X-ray unit.
Keep loose items of clothing, hair and jewellery tucked away safely.
2.1 Radiation protection
Protect yourself from radiation when you check the radiation beam alignment.
The room in which the X-ray unit is to be installed and the position from where the user is
to operate the equipment MUST be correctly shielded from radiation. Since radiation
safety requirements vary from country to country and state to state it is the responsibility of
the installer to ensure that all safety regulations are met.
Printed copies of this document are considered uncontrolled.
7535.13.Rev001 08.07.2018
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