7
1.2 Information and recommendations relating to
safe use
-Safety information and recommendations.
-The device is equipped with a set of standard accessories. For reasons
of safety, reliability and conformity with the Medical Devices Directive
93/42/EEC, use only original accessories or accessories approved by the
manufacturer.
-The device is equipped with a special long life thermal head writing
system, which allows maximum writing precision. To avoid frequent and
costly replacements and repairs, always use the original paper or paper
approved by the manufacturer. The manufacturer will not accept liability
for any damage to the device or any other adverse effect caused by the
use of unsuitable paper.
-Do not subject the device to impact or excessive vibrations.
-Do not allow liquids to penetrate inside the device. If this should
accidentally occur, have the device tested by an Authorized Assistance
Centre to verify its functional efficiency, before using it again.
-Make sure that the value of the supply voltage corresponds to that
indicated on the data plate of the device.
-If you are using the device in connection with others, ensure that: all
connections are made by skilled persons; all connections comply with
safety regulations; all other devices connected respond likewise to
regulations. Non compliance with regulations can cause physical harm to
the patient connected and to the person operating the device. Should it
be difficult to obtain the necessary information for assessing the risk of
the individual connections, apply directly to the manufacturers
concerned or avoid making the connections.
-In the event of other equipment being connected directly or indirectly to
the patient, check for the possible risks caused by the sum of the
leakage currents on the body of the patient.
-The device is protected against defibrillation discharges in accordance
with IEC standard 601 1 25; to ensure that the signal is restored, use
only original electrodes or electrodes responding to IEC and AAMI
standards.
-If an electrosurgical scalpel is in use, the patient cable should be
disconnected from the device.
-At all events, when defibrillators or high frequency surgical devices are
being used at the same time, it is essential to take the greatest care. If
there is any doubt when such devices are in use, disconnect the patient
from the electrocardiograph temporarily.
-The device recognizes the impulses generated by a pacemaker and does
not interfere with its operation, as prescribed by standards in use at the
time of drafting this manual.
-Avoid exposing the equipment to extreme temperatures, excessive dust
or dirt, and very salty or damp environments; observe the ambient
conditions described in detail under the "Technical s ecifications”
heading.
