Laser Surgical Unit diomax
®
Revision 6
19
3.9
Laser Safety Officer
According to the German accident prevention directive BGV B2 (laser radiation), the operator
must appoint a laser safety officer in writing. The laser safety officer is responsible for the
following:
•
Implementation of safety measures
•
Instruction of all persons working with the device in the safety measures and operation of
the device
•
Marking of the laser area with signs
•
Check of the warning signals
•
Availability of the laser protection goggles
•
Safe storage of the keys
•
Correct connection of the device in case of relocation
•
Keeping of the medical product log
3.10
User
The user is responsible for safe and proper use of the medical laser system. He or she must
ensure that all safety precautions are complied with, and be familiar with the laser-specific
surgical technique.
3.11
Electrical Safety
The device conforms to protection class 1 (IEC 60601), which means that it must be connected
to a properly earthed mains according to its technical data (see section 11 “Tecnical Data”,
page 67).
•
Use only the mains cable included in the delivery.
•
Mains cable and plugs must not show any signs of damage.
•
The laser system must never be activated if any part of the casing is not attached
correctly. If the casing is not properly closed, laser radiation may escape uncontrollably,
and dangerous electrical voltages or currents may be exposed.
3.12
Earthing of the Device
The device is earthed via the earthing conductor in the mains cable. This is an indispensable
prerequisite for safe operation of the device. Proper earthing is ensured if the mains cable is
connected according to the VDE regulations.
The equipotential bonding required for use of the device in certain operation areas (e. g.
during intracardiac operations) can be established via the green-yellow equipotential bonding
cable.
