Welch Allyn ELI 150 Service Manual page 6

User Safety Information
Warning:
Caution:
Note:
Federal law restricts this device for sale to or on the order of a physician.
Warning(s)

Device (electrocardiograph, Class I) captures and presents data reflecting a patient's physiological condition that when
reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be
used as a sole means for determining a patient's diagnosis.

To ensure that electrical safety is maintained during operation from AC (~) power, the device must be plugged into a
Hospital Grade outlet.

To maintain designed operator and patient safety, peripheral equipment and accessories used that can come in direct patient
contact, must be in compliance with UL 2601-1, IEC 601-1 and IEC 601-2-25.

Patient cables intended for use with the ELI 150 include series resistance (9 Kohm minimum) in each lead for defibrillation
protection. Patient cables should be checked for cracks or breakage prior to use.

Conductive parts of the patient cable, electrodes and associated connections of Type CF applied parts, including the neutral
conductor of the patient cable and electrode should not come into contact with other conductive parts, including earth
ground.

To maintain designed operator and patient safety, only use parts and accessories supplied with the device and available
through Mortara Instrument, Inc.

ECG electrodes could cause skin irritation and should be examined for signs of irritation or inflammation.

To prevent possible infection, single use components (e.g., electrodes) should be limited to one-time use only.

To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with device or
patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize
harm to the patient.

A possible explosion hazard exists; do not use the device in the presence of flammable anesthetics.

Before attempting to use the device for clinical applications the operator must read and understand the contents of the
manual and any documents accompanying the device.

Where the integrity of external protective earth conductor arrangement is in doubt, the ELI 150 shall be operated from its
internal electrical power source.
iv
Means there is the possibility of personal
injury to you or others.
Means there is the possibility of damage to
the equipment.
Provides information to further assist in the
use of the device.