Product Manual

USER SAFETY INFORMATION
10
• A possible explosion hazard exists. Do not use the device in the presence of a flammable anesthetic mixture.
• Where the integrity of external protective earth conductor arrangement is in doubt, the device shall be
operated from its internal electrical power source.
• Medical devices have been designed to have a higher degree of protection against electric shock than, for
instance, information technology equipment because patients often are connected to multiple devices
and also may be more prone to the adverse effect of electric currents than healthy persons. All equipment
that is connected to the patient, can be touched by the patient, or can be touched by another person
while that person touches the patient at the same time, should have the same level of protection against
electric shock as medical equipment. The ELI 150c/ELI 250c is a medical device that has been designed to
be connected to other devices for the purpose of receiving and transmitting data. Certain measures must
be taken to prevent the risk of excessive electric current flow through the operator or patient when
connected:
• All electrical equipment that is not medical electrical equipment must be placed outside of the
“patient environment,” defined by applicable safety standards to be at least 1.5 meters (5 feet) from
the patient. Alternatively, non-medical equipment may be provided with additional protection such
as an additional protective earth connection.
• All medical electrical equipment that has a physical connection to the ELI 150c/ELI 250c or the
patient, or is in the patient environment must comply with applicable safety standards for medical
electrical devices.
• All electrical equipment that is not medical electrical equipment and has a physical connection to
the ELI 150c/ELI 250c must comply with applicable safety standards, such as IEC 60950 for
information technology equipment. This includes information network equipment connected
through the LAN connector.
• Conductive (metal) parts that can be touched by the operator in normal use and that are connected
to non- medical equipment should not be brought into the patient environment. Examples are
connectors for shielded Ethernet or USB cables.
• If multiple devices are connected to each other or to the patient, device chassis and patient leakage
currents may be increased, and should be measured for compliance with applicable standards for
medical electrical systems.
• Avoid the use of portable multiple socket outlets. If used and not compliant with medical
electrical device standards, an additional protective earth connection is required.
• After defibrillation pulse, electrocardiograph has a maximum recovery time of 5 seconds.
• To prevent electric shock due to unequal ground potentials that may exist between points of a
distributed network system or fault conditions in external network connected equipment, network
cable shielding (where used) must be connected to protective earth ground appropriate to the area
where the device is used.
• The device has not been designed for use with high-frequency (HF) surgical equipment and does not
provide a protective means against hazards to the patient.
• When the 40 Hz filter is used, the frequency response requirement for diagnostic ECG equipment
cannot be met. The 40 Hz filter significantly reduces high-frequency components of the ECG and
pacemaker spike amplitudes, and is recommended only if high-frequency noise cannot be reduced by
proper procedures.