Product Manual

9
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 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.
• 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. Contact Welch Allyn service for additional
training options.
• To ensure that electrical safety is maintained during operation from AC (~) power, the device must be
plugged into a hospital-grade outlet.
• Only use parts and accessories supplied with the device and/or are available through Welch Allyn, Inc.
• Patient cables intended for use with the device 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.
• 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.
• 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.