En - Isolating Transformer; Intended Use; Safety Information - natus Dantec KEYPOINT Instructions D'utilisation

EN – Isolating Transformer

Intended Use

The Isolating Transformer is intended for
applications where medical devices require
improved electrical isolation and/or reduced
leakage current to comply with existing safety
standards.

Safety Information

This device has been designed and tested in
accordance with IEC 60601-1 Medical
Electrical Equipment standard.
To ensure a safe operation and to maintain the
device in a safe condition, follow the instruc-
tions in this manual and pay special attention
to all warnings and cautions.
DANGER Possible explosion hazard if used in
the presence of flammable anaesthetics.
WARNING Use only protectively-earthed
power cords/cables.
WARNING Any interruption to the protective
earth conductor inside or outside the device,
or disconnection of the protective earth con-
nector is likely to make the device dangerous.
- Intentional interruption is prohibited.
- Check regularly the protective earth (ground)
conductor.
WARNING The device is not MRI compatible.
WARNING Electrical equipment for medical
use requires special EMC precautions, and
needs to be installed and serviced according
to the EMC documentation of the system.
CAUTION Electric shock hazard. Do not
remove cover. Refer servicing to qualified
service personnel.
CAUTION Install and use the device in
horizontal position only. –Make sure to use
the accompanying screws or feet for mounting
on the bottom of the device.
CAUTION The mains plug must only be in-
serted in a mains socket-outlet provided with a
protective earth contact.
CAUTION Do not use an extension cord to
power the device.
NOTE Ensure the device is positioned in such
a way to allow easy disconnection from the
mains, if needed.
NOTE This device is part of a medical system,
and is intended to be used by qualified medi-
cal / technical personnel only.
For the combination of this device with other
devices and / or for its connection to installa-
tions, the following applies:
 When connecting medical equipment being
supplied from an outlet located in a non-
medically used room, or when connecting
non-medical electrical equipment to this
device, pay attention to the IEC 60601-1
requirements.
 When the device is connected to its mains
supply, connectors may be live, and any
opening of covers or removal of parts
possible only with the aid of a tool is likely
to expose live parts.
 The device must be disconnected from all
voltage sources before being opened for any
adjustment, replacement, maintenance or
repair.
 Service must be referred to Natus Medical
Incorporated authorized service personnel,
except for such works described in this
manual as being performed by the operator.
 Make sure that only fuses with the required
rated current and of the specified type are
used for replacement. The use of makeshift
fuses and the short-circuiting of fuse hold-
ers are prohibited.
 Where more than one piece of equipment is
connected to a patient, attention must be
paid to the summation of patient leakage
currents.
 Whenever it is likely that the protection has
been impaired, the device shall be made
inoperative and be secured against any
unintended operation.
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Dantec Keypoint