USER SAFETY INFORMATION
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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 (stress test system) 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 Mortara 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.
The device is supplied with a power isolation transformer that must be used to maintain designed operator
and patient isolation from power source. The power isolation transformer 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 60601-1, and IEC 60601-2-25. Only use
parts and accessories supplied with the device and available through Mortara Instrument, Inc.
All signal input and output (I/O) connectors are intended for connection of only those devices complying with
IEC 60601-1, or other IEC standards (e.g., IEC 60950), as appropriate to the device. Connecting additional
devices to the device may increase chassis and/or patient leakage currents. To maintain operator and patient
safety, consideration should be given to the requirements of IEC 60601-1-1, and leakage currents should be
measured to confirm no electric shock hazard exists.
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 electrode, should not come into contact with other
conductive parts, including earth ground.
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