USER SAFETY INFORMATION
7
Conductive parts of the acquisition module(s), electrodes, and associated connections of type CF applied parts,
including the neutral conductor of the acquisition module(s) and electrodes, should not come into contact with
other conductive parts including earth ground.
ECG electrodes could cause skin irritation; patients should be examined for signs of irritation or inflammation.
To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with the
device or acquisition module(s). Additionally, proper placement of defibrillator paddles in relation to the
electrodes is required to minimize harm to the patient.
This device does not automatically switch between direct or wireless acquisition modules. Clinician must
choose the type of acquisition module before ECG acquisition. If your device is equipped with a receiver for a
wireless acquisition module, always make sure that you are receiving data from the expected module.
This device was designed to use the electrodes specified in the user manual. Proper clinical procedure must
be employed to prep the electrode sites and to monitor the patient for excessive skin irritation,
inflammation, or other adverse reactions. Electrodes are intended for short-term use and should be removed
from the patient promptly following testing.
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 380 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 380 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 380 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.
