En - Isolating Transformer; Intended Use; Safety Information - natus Dantec Keypoint Manuel D'utilisation Du Matériel

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 instructions
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 connector
is likely to make the device dangerous.
- Intentional interruption is prohibited.
- The protective earth (ground) conductor should
be checked regularly.
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 inserted
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 medical /
technical personnel only.
For the combination of this device with other
devices and / or for its connection to installations,
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
safety requirements for medical electrical
systems.
• 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.
– 5 –