Planmeca ProOne Technical Manual page 6

CHAPTER A
GENERAL & TECHNICAL DATA
CAUTION GENERAL SAFETY RULES
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 cord is a special part and always needs to be exchanged to
a part ordered especially from PLANMECA. The mains cord can only
be exchanged by a qualified authorized service technician trained by
PLANMECA.
Periodical maintenance as described in this manual must be
performed on a regular basis, to ensure the safety and image quality
of the X-ray unit.
Some procedures described in this manual could be dangerous if not
followed as stated.
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)
- 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 section 7
"EMC INFORMATION" on page 14.
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, section 7 "EMC INFORMATION" on
page 14.
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.
NOTE The display values shown in this manual are only examples and should not be
interpreted as recommended values unless otherwise stated.
A-2 Planmeca ProOne
WARNINGS AND CAUTIONS
Technical Manual