Safety - Sirona Orthophos XG 3 Installation Instructions Manual

Sirona Dental Systems GmbH
Installation Instructions ORTHOPHOS XG 3

1.2 Safety

DANGER
Fixed connection!
The installation of a power plug instead of the pre -
scribed fixed (hard-wired) connection violates interna -
tional medical regulations and is prohibited.
In case of a fault, you would thus endanger the life and
limb of the patient, the operator or other persons.
WARNING
Installation and startup must be carried out in accor -
dance with the requirements stated in our Installation
Instructions.
WARNING
Installation and startup may be carried out only by per -
sonnel specifically authorized by SIRONA.
WARNING
Any person who assembles or modifies a medical elec -
trical system complying with the standard IEC 60
601-1-1
(safety requirements for medical electrical equipment)
by combining it with other equipment is responsible for
ensuring that the requirements of this regulation are
met to their full extent for the safety of the patients, the
operators and the environment.
If any equipment not approved by SIRONA is connect -
ed, it must comply with the applicable standards:
- IEC 60950-1 for information technology equipment
and
- IEC 60 601-1 for medical electrical equipment.
See also "On-site installation, dimensions, technical
data" and the "Compatibility list/Declaration of
conformity" issued by the system integrator.
In case of doubt, contact the manufacturer of the sys -
tem components.
WARNING
Wireless phone interference with medical electrical
equipment:
To ensure safe operation of medical electrical equip -
ment, the use of mobile wireless phones in practice or
hospital environments is prohibited.
60 51 416 D 3352
D 3352.031.03.18.02
CAUTION
The unit contains class 1 lasers.
Keep a distance of at least 4" (10 cm) between eye and la -
ser. Do not stare into the beam.
Do not use the system with any other lasers, and do not
make any changes to settings or processes that are not de -
scribed in these operating instructions. This may lead to a
dangerous exposure to radiation.
NOTICE
Use an ESD wrist band during installation.
Connect it to the
protective ground wire.
NOTICE
When opening the unit:
Please observe the usual precautionary
measures for handling PCBs (ESD).
Touch a ground point to discharge static elec -
tricity before handling any components.
NOTICE
Extreme fluctuations of temperature may cause condensa -
tion inside the unit. Do not switch the unit on before it has
reached normal room temperature.
1 Before you begin
1.2 Safety
7