USER SAFETY INFORMATION
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•To avoid potential for spread of disease or infection, single-use disposable components (e.g., electrodes) must
not be reused. To maintain safety and effectiveness, electrodes must not be used beyond their expiration date.
•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 230 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 230 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 230 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.
•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.
