Intended Use
1-4 Introduction
Intended Use
The M4735A Heartstream XL Defibrillator/Monitor is for use in the hospital
by qualified medical personnel trained in the operation of the device and qual-
ified by training in basic life support, advanced cardiac life support, or
defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the
M4735A Heartstream XL Defibrillator/Monitor is suitable for use by medical
personnel trained in basic life support that includes the use of an AED.
When operating as a defibrillator/monitor in Manual Mode, the M4735A
Heartstream XL Defibrillator/Monitor is suitable for use by emergency medi-
cal personnel trained in advanced cardiac life support.
Defibrillation Therapy
Defibrillation therapy is the definitive method for termination of a variety of
potentially fatal arrhythmias. The M4735A Heartstream XL Defibrillator/
Monitor provides this therapy through the application of a brief biphasic pulse
of electricity to the cardiac muscle. This electrical energy is transferred
through attached paddles or disposable multifunction defib electrode pads
applied to the patient’s bare chest.
NOTE Successful resuscitation is dependent on many variables specific to the
patient’s physiological state and the circumstances surrounding the patient
event. Failure to have a successful patient outcome is not a reliable indicator
of defibrillator/monitor performance. The presence or absence of a muscular
response to the transfer of energy during electrical therapy is not a reliable
indicator of energy delivery or device performance.
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