User Manual

iv
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 equipment.
Note
Provides information to further assist in the
use of the device.
Federal law restricts this device for sale to and use by or on the order
of a physician.
Warning
• Device (Ambulatory X12+) transmits data reflecting a patient’s physiological condition to a properly
equipped electrocardiograph and 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 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.
• FCC Warning (Part 15.21): Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
• To maintain designed operator and patient safety, only use parts and accessories supplied with the device
and available through Mortara Instrument, Inc.
• 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 mixtures with air,
oxygen or nitrous oxide.
• Defibrillation protection is guaranteed only if the original patient cable is used.
• Simultaneous connection to other equipment may increase leakage current.
• Some stimulators may cause interference with the signal.
• ECG electrodes could cause skin irritation and should be examined daily. Reposition and change
electrodes every 24 hours, though it may be necessary to do so sooner if signs of irritation or inflammation
occur.
• 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.