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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.
WARNINGS
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 captures 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.
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 applications, 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 Welch
Allyn, 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.
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.
