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Intended Use; Indications For Use; Chapter 9 Monitoring Co - Philips Efficia DFM100 Instructions For Use Manual

Defibrillator/monitor.
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1: Introduction
The device automatically stores critical event data such as Event Summaries and Vital Signs
Trending.
In clinical mode, the Efficia DFM100 continually records data about a patient in an Event Summary
record. The recorded data includes vital signs (such as SpO
therapy events (such as shock delivered). The Event Summary can be printed or exported after the
patient event is completed.
You can also transfer the data to a USB drive and download it to a compatible version of Philips' data
management solution – HeartStart Event Review Pro.
The Efficia DFM100 is powered by a rechargeable Lithium Ion battery. Available battery power is
determined by viewing the battery power indicators located on the front of the device, the icon on
the display, or by checking the gauge on the battery itself. Additionally, AC Power may be applied as
a secondary power source and for continual battery charging.
The Ready For Use (RFU) indicator provides a constant status update, indicating the Efficia
DFM100 is ready for use, needs attention or is unable to deliver therapy. The device performs
automated tests on a regular basis and displays results on the RFU indicator. In addition, performing
specified Operational Checks ensures the Efficia DFM100 is functioning properly.
The Efficia DFM100 is highly configurable to better meet the needs of diverse users, including the
EMS (Emergency Medical Services) environment. Be sure to familiarize yourself with your device's
configuration before using the Efficia DFM100. See

Intended Use

The Efficia DFM100 is intended for use in a hospital or EMS setting by qualified medical personnel
trained in the operation of the device and qualified by training in basic life support, advanced life
support or defibrillation.
When operating as a semi-automated external defibrillator in AED Mode, the Efficia DFM100 is
suitable for use by medical personnel trained in basic life support that includes the use of an AED.
When operating in Monitor, Manual Defibrillation or Pacing modes, the Efficia DFM100 is suitable
for use by healthcare professionals trained in advance life support.

Indications for Use

The Efficia DFM100 is a defibrillator/monitor. The device is for use by qualified medical personnel
trained in the operation of the device and certified by training in basic life support, advanced life
support or defibrillation. It must be used by or on the order of a physician.
AED Therapy
Indications for Use: AED Mode is used in the presence of suspected cardiac arrest on patients that
are unresponsive, not breathing and pulseless.
Contraindications for Use: Patients that are conscious and have a pulse.
Manual Defibrillation
Indications for Use: Asynchronous defibrillation is the initial treatment for ventricular fibrillation
and ventricular tachycardia in patients that are pulseless and unresponsive.
Synchronous defibrillation (cardioversion) is indicated for the termination of atrial fibrillation.
Contraindications for Use: For asynchronous defibrillation - patients that are conscious and have a
pulse; patients that do not have a pulse and are in a non-shockable rhythm (asystole or pulseless
electrical activity). For synchronous defibrillation - patients that are pulseless and unresponsive with
ventricular fibrillation, pulseless ventricular tachycardia, asystole or pulseless electrical activity.
2
, and heart rate), ECG wave data, and
2
"Configuration"
on page 145 for more details.
Overview

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