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User Safety Information
Warning:
Means there is the possibility of personal injury to you or others.
Caution:
Means there is the possibility of damage to the device.
Note:
Provides information to further assist in the use of the device.
Warning(s)
·
This manual gives important information about the use and safety of this device. Deviating from operating
procedures, misuse or misapplication of the device, or ignoring specifications and recommendations could
result in increased risk of harm to users, patients and bystanders, or damage to the device.
·
Device transmits data reflecting a patient’s physiological condition to a properly equipped receiving device
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.
·
Users are expected to be licensed clinical professionals knowledgeable about medical procedures and patient
care, and adequately trained in the use of this device. Before attempting to use this device for clinical
application, the operator must read and understand the contents of the user manual and other accompanying
documents. Inadequate knowledge or training could result in increased risk of harm to users, patients and
bystanders, or damage to the device.
·
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 60601-1, IEC 60601-1 and IEC 60601-2-25. Only use
parts and accessories supplied with the device and available through Mortara Instrument, Inc.
·
Patient cables intended for use with the device include series resistance (7 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 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
device or patient cables. Additionally, proper placement of defibrillator paddles in relation to the electrodes is
required to minimize harm to the patient.
·
Defibrillation protection is guaranteed only if the original patient cable is used. Any modification of this
device may alter defibrillator protection.
·
This device was designed to use the electrodes specified in this manual. Proper clinical procedure must be
employed to prep the electrode sites and to monitor the patient for excessive skin irritation, inflammation, or
