Requirements; Installation/Setup Room - Air Techniques ProVecta 3D Prime Installation Instructions Manual

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Installation
EN-
Installation
US
Only qualified specialists or persons
trained by Air Techniques may install,
connect, and commission the unit.
6

Requirements

6.1

Installation/setup room

The room chosen for set up should fulfil the fol-
lowing requirements:
– Closed, dry room.
– It should not be a room made for another pur-
pose (e.g. boiler room or wet cell).
– There should be no major fields of interference
(e.g. strong magnetic fields) present that can
interfere with the proper operation of the unit.
– The required environmental conditions are met
(refer to "Technical Data" in the operating
instructions).
Portable and mobile HF communication applian-
ces can interfere with the effectiveness of electri-
cal medical devices.
Do not stack the unit next to or together with
other appliances.
If, however, this unit is operated next to other
units or stacked with other units, monitor the
unit carefully in the configuration selected in
order to ensure normal operation.
WARNING
Risk of explosion due to inflammation
of combustible materials
Do not use the unit in rooms in which
combustible mixtures may be present,
e.g. in operating rooms.
Radiation protection
Comply with all applicable X-ray protection reg-
ulations and X-ray protection measures.
Use the prescribed X-ray protection equip-
ment.
In order to reduce the level of X-ray exposure,
we recommend the use of bismuth, lead
shielding or protective aprons, especially for
children and teenagers.
24
The persons operating the equipment must
keep away from the X-ray unit while the expo-
sure is being taken. The minimum distance
required by the law must be maintained.
Children and pregnant women must consult a
doctor before recording an X-ray image.
No person other than the patient is permitted
to be present in the radiation room without X-
ray protection measures. In exceptional cir-
cumstances another person may be present to
provide assistance, but this must not be a
member of the surgery staff. When the expo-
sure is being taken, make sure that you main-
tain visual contact with the patient and the unit
and keep talking to the patient.
The radiation room must be lockable to prevent
entry by unauthorized persons.
If a fault occurs, abort the exposure immedi-
ately by releasing the trigger button.
Information about electrical connections
WARNING
Electric shock due to incorrectly con-
nected device
Never install a mains plug instead of
the fixed connection.
Make sure that the electrical connections to the
mains power supply are established in accord-
ance with current valid national and local regu-
lations and standards governing the installation
of low voltage units in medical facilities.
The connection to the mains supply must be a
fixed connection that cannot be disconnected
without the use of tools. Plug-in connections
(power outlet/plug) are not permissible.
Install an all-pole disconnection unit (all-pole
switch) in the electrical connection to the mains
power supply. This must include the creepage
distances and air gaps defined in IEC 61058-1
for a mains voltage peak of 4 kV.
It must be possible to secure the disconnect
switch so that it cannot be inadvertently
switched back on again.
The disconnection unit (switch) must be
easily and safely accessible.
Note the current consumption of the devices
that are to be connected.
2210201032L41 2108V005

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