References
1 Thomas Schneider, Patrick R. Martens, Hans Paschen, Markku Kuisma, Benno Wolcke; Bradford E. Gliner,
James K. Russell, W. Douglas Weaver, Leo Bossaert, Douglas Chamberlain, for the Optimized Response
to Cardiac Arrest (ORCA) Investigators. Multicenter, Randomized, Controlled Trial of 150-J Biphasic Shocks
Compared With 200- to 360-J Monophasic Shocks in the Resuscitation of Out-of-Hospital Cardiac Arrest
Victims. Circulation. 2000; 102: 1780-1787.
2 Wanchun Tang, Max Harry Weil, Dawn Jorgenson, Kada Klouche, Carl Morgan, Ting Yu, Shijie Sun, David
Snyder. Fixed -energy biphasic waveform defibrillation in a pediatric model of cardiac arrest and resuscitation.
Crit Care Med 2002; 30:2736-2741.
3 Dianne L. Atkins, Dawn B. Jorgenson. Attenuated Pediatric Electrode Pads for Automated External Defibrillator
Use in Children. Resuscitation. 66 (2005) 31-37.
4 ECC GUIDELINES. Part 1: Introduction to the International Guidelines 2000 for CPR and ECC. A Consensus on
Science. Circulation. 2000;102(suppl I):I-1–I-11.
5 Adult advanced cardiac life support: The European Resuscitation Council guidelines 1992 (abridged). British
Medical Journal (BMJ). 1993; 306: 1589-93.
6 The 1998 European Resuscitation Council guidelines for adult advanced life support. BMJ. 1998 Jun 20;
316(7148): 1863–1869.
7 The 1998 European Resuscitation Council guidelines for adult single rescuer basic life support. BMJ. 1998 Jun
20; 316(7148): 1870–1876.
8 Nolan, JP et al., on behalf of the ERC Guidelines Writing Group 1. European Resuscitation Council Guidelines
for Resuscitation 2010 Section 1. Executive summary. Published online 19 October 2010, pages 1219 – 1276.
9 Neumar RW et al. Part 1: executive summary: 2015 American Heart Association Guidelines Update for
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S315–S367.
10 Monsieurs, KJ et al on behalf of the ERC Guidelines 2015 Writing Group. European Resuscitation Council
Guidelines for Resuscitation 2015Section 1. Executive summary. Resuscitation. 95 (2015).1-80.
11 Survive cardiac arrest: https://depts.washington.edu/survive/index.php, accessed July 24, 2016. Mickey
Eisenberg.
12 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and
Reporting Arrhythmia Analysis Performance, Incorporating New Waveforms and Enhancing Safety. A
Statement for Health Professionals from the American Heart Association (AHA) Task Force on Automatic
External Defibrillation. Subcommittee on AED Safety and Efficacy. Circulation. 1997: 95. 1677-1682.
Potential Adverse Effects of the Device on Health
The potential adverse effects (e.g. complications) associated with use of an automated external defibrillator include,
but are not limited to, the following:
• Failure to identify shockable arrhythmia.
• Failure to deliver a defibrillation shock in the presence of VF or pulseless VT, which may result in death
or permanent injury.
• Inappropriate energy, which could cause failed defibrillation or post-shock dysfunction.
• Myocardial damage.
• Fire hazard in the presence of high oxygen concentration or flammable anesthetic agents.
• Incorrectly shocking a pulse sustaining rhythm and inducing VF or cardiac arrest.
• Bystander shock from patient contact during defibrillation shock.
• Interaction with pacemakers.
• Skin burns around the defibrillation pads placement area.
• Allergic dermatitis due to sensitivity to the materials used in the defibrillation pads construction.
• Minor skin rash.
9.
Tec
hnical Specifications
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DAC-U2510EN-BF rev H
