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1.8.5. CONDENSATE FORMATION
Following strong temperature oscillations, condensate may form in the X-ray device. Activate the X-ray device only
after an adequate ambient temperature has been reached. See the chapter "Ambient characteristics".
1.8.6. ELECTROSTATIC DISCHARGE
Electrostatic discharge (ESD).
Electrostatic discharge from persons may cause damage to the electronic components in the event of contact.
Generally, damaged components must be replaced. The repair must be carried out by qualified technicians.
Do not touch the parts at risk marked with the symbol
1.8.7. EXPOSURE TO LASER RADIATION
The system contains some Class 1 laser diodes in compliance with IEC 60825-1. Three of them are positioned on the
X-ray generator and one on the chin support base.
Both the patient and the operator may be dazzled by laser traces.
-
Do not look directly into the laser beam. Be careful that the laser beam does not hit the patient's eye.
-
Keep a distance of at least 10 cm between the eye and the laser.
The position of the laser sources is indicated with the following symbol
1.8.8. ELECTROMAGNETIC SAFETY
Do not use electronic devices that do not comply with IEC 60601-1-2: 2007 in proximity of life-support equipment (e.g.
pacemakers or heart stimulators) and hearing aids.
In healthcare facilities, before using any electronic device, always make sure that it is compatible with the other devices
present, including the X-ray device.
Guidance and manufacturer's declaration – Electromagnetic emissions
The GIANO/VG3is suitable for use in the specified electromagnetic environment. The purchaser or user of the
GIANO/VG3 should assure that it is used in an electromagnetic environment as described below:
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
14
.
Compliance
This GIANO/VG3 uses RF energy only for its internal
function.
Group 1
Therefore, the RF emission is very low and not likely
to cause any interference in nearby electronic
equipment.
This
Class B
establishments, including domestic establishments
and those directly connected to the public low-voltage
Class A
power supply network that supplies buildings used for
domestic purpose.
Complies
OPERATOR'S MANUAL
.
Electromagnetic Environment
GIANO/VG3
is
suitable
for
use
in
all
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