Chapter A: GENERAL & TECHNICAL DATA 4 WARNINGS AND CAUTIONS
Technical manual Planmeca ProOne 7
GENERAL SAFETY RULES
Modification of the X-ray unit is strictly prohibited.
The X-ray unit must be serviced only by qualified personnel, trained by
PLANMECA. Repairs and parts replaced by unqualified personnel carry no
warranty.
The mains cable is a special part which should always be replaced with a new one
ordered from PLANMECA. The mains cable must always be fitted by a qualified
authorized service technician who has been trained by PLANMECA.
To ensure the safety and image quality of the X-ray unit, periodical maintenance as
described in this manual must be performed on a regular basis.
Some procedures described in this manual could be dangerous if not followed as
stated.
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)
- protectively grounded.
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 Cl. 16.1, 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 Cl. 16.1.
If in doubt, contact your service technician or local representative for help.
EMC requirements have to be considered, and the equipment must be installed and put into
service according to the specific EMC information provided in section 9 "EMC
INFORMATION" on page 23.
Portable and mobile RF communications equipment can affect the X-ray unit. For minimum
distance between portable and mobile RF communications equipment and the X-ray unit,
see section 9 "EMC INFORMATION" on page 23.
FOR PERMANENTLY INSTALLED X-RAY UNITS
The X-ray unit can be disconnected from the mains power supply by turning the external
mains switch to the off position.
FOR X-RAY UNITS WITH DETACHABLE POWER SUPPLY CORD
The X-ray unit can be disconnected from the mains power supply by unplugging the power
cable.
Never place or hang any objects on any part of the X-ray unit.
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