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Philips HeartStart MRx - Intended Use

Philips HeartStart MRx
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1 Introduction Intended Use
4
Optional Pacer Mode offers noninvasive transcutaneous pacing therapy. Pace pulses are delivered
through multifunction electrode pads, using a monophasic waveform. If desired, use of Pacer Mode
may be password protected.
The HeartStart MRx is powered by rechargeable lithium ion batteries. Available battery power is easily
determined by viewing the convenient battery power indicators located on the device display or by
checking the gauge on the battery itself. Additionally, an external AC or DC Power Module may be
applied as a secondary power source and for continual battery charging.
The HeartStart MRx performs Automated Tests on a regular basis. The results of these tests are
reported to the Ready For Use (RFU) indicator. The prominently displayed RFU indicator
communicates the status of your device, letting you know it is operating correctly, needs attention, or is
unable to deliver therapy. In addition, performing the specified Operational Check ensures that the
HeartStart MRx is functioning properly.
The HeartStart MRx automatically stores critical event data, such as Event Summaries, 12-Lead
Reports and Vital Signs Trending, in its internal memory. The HeartStart MRx also enables you to
store data and event information on an optional data card for downloading to Philips’ data
management solution, HeartStart Event Review Pro or Q-CPR Review.
The HeartStart MRx is highly configurable to better meet the needs of diverse users. Be sure to
familiarize yourself with your device’s configuration before using the HeartStart MRx. See Chapter 17
“Configuration” for more details.
Intended Use
The HeartStart MRx is intended for use in hospital and pre-hospital settings by qualified medical
personnel trained in the operation of the device and qualified by training in basic life support,
advanced cardiac life support or defibrillation.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart MRx is
suitable for use by medical personnel trained in basic life support that includes the use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart MRx is suitable for use by
healthcare professionals trained in advanced cardiac life support.
The SMART Biphasic waveform utilized in the HeartStart MRx has previously undergone clinical
testing in adults. These trials support the waveform’s effectiveness for defibrillation of ventricular
tachyarrhythmias at 150J. There are currently no clinical studies related to the use of the SMART
Biphasic waveform in pediatric applications.

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