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Manual Defibrillation:
Indications
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Energy delivered in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 12 defibrillator/monitor is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing:
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute myocardial infarction.
Pulse Oximetry:
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiologic parameters such as shock, evaluation of perfusion during dysrhythmias, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully. It is intended for use on adult and pediatric patients.
Invasive Pressure Monitoring:
Indications
The LIFEPAK 12 invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer. It may be used on the adult or pediatric patient.

The LIFEPAK 12 defibrillator/monitor was designed for use in a variety of hospital and pre-hospital settings including emergency departments, critical care areas, and air and ground ambulances. The LIFEPAK 12 defibrillator/monitor is powered by either a battery or AC power. LIFEPAK 12 defibrillator/monitor features include manual and automated external defibrillation, noninvasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry, synchronized cardioversion. noninvasive blood pressure monitoring, end-tidal CO2 monitoring, and invasive pressure monitoring.
The LIFEPAK 12 defibrillator/monitor has been modified with new setup options in automated external defibrillation (AED) mode to give medical directors or physicians flexibility in establishing their AED protocols including consistency with the recently updated 2005 AHA Guidelines for CPR and ECC.

The provided text describes a 510(k) summary for the Medtronic LIFEPAK® 12 Defibrillator/Monitor, which was modified with new setup options in automated external defibrillation (AED) mode. However, the document does not contain any study data, acceptance criteria for performance, or details about how the device's performance was evaluated against specific metrics.

It primarily focuses on:

• Device Description and Intended Use: Explaining what the LIFEPAK 12 is, its features, and for what purposes it's used.
• Indications for Use and Contraindications: Detailing when each function (Manual Defibrillation, AED, Pacing, ECG, Oximetry, NBP, EtCO2, Invasive Pressure) should be applied and when it should not.
• Substantial Equivalence: Stating that the modified device is substantially equivalent to a previously cleared version, with the only change being new setup options for AED mode.
• Regulatory Information: Classification, contact person, and the FDA's clearance letter.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The document indicates a "Summary of Design Controls" and a "declaration of conformity to design controls," implying that internal testing and validation were performed to support substantial equivalence, but the specifics of these tests (e.g., performance metrics, sample sizes, ground truth establishment) are not included in this 510(k) summary.

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