Emergency Care

LIFEPAK 15 monitor/defibrillator

Brief summary of indications and important safety information

LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. INTENDED USE: LIFEPAK 15 intended for use by trained medical personnel out-of-doors, in indoor emergency care settings, and is designed to be used for ground transportation. Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation (AED) mode intended for use on patients ≥8 years of age.

INDICATIONS FOR USE – MANUAL DEFIBRILLATION: Indicated for termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia. CONTRAINDICATIONS - MANUAL DEFIBRILLATION: Contraindicated in treatment of PEA and asystole. AED MODE: To be used only on patients in cardiopulmonary arrest. Patient must be unconscious, pulseless, and not breathing normally before using defibrillator to analyze patient’s ECG rhythm. In AED mode, the LIFEPAK 15 is intended for use on pediatric patients ≥ 8 years of age. CONTRAINDICATIONS - AED MODE: None known.

INDICATIONS FOR USE – MONITORING. AQUIRING 12-LEAD ECG: 12-lead electrocardiogram used to identify, diagnose, and treat patients with cardiac disorders and is useful in early detection and prompt treatment of patients with STEMI. MONITORING SPO2, SPCO, AND SPMET: Pulse oximetry indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions. MONITORING NONINVASIVE BLOOD PRESSURE: Intended for detection of hypertension or hypotension and monitoring blood pressure trends in patient conditions. NIBP monitoring not indicated for neonatal patients <1-month-old. MONITORING ETCO2: Used to detect trends in level of expired CO2, used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care. MONITORING INVASIVE PRESSURE: Indicated for use in patients who require continuous monitoring of physiological pressures to rapidly assess changes in patient’s condition or response to therapy. May also be used to aid diagnosis. MONITORING CONTINUOUS TEMPERATURE: Indicated for use in patients who require continuous monitoring of body temperature. MONITORING CONTRAINDICATIONS: None known.

Operating Instructions provide important information to help you operate LIFEPAK 15. Become familiar with all terms and warnings. GENERAL DANGER: Explosion hazard. GENERAL/THERAPY/MANUAL DEFIBRILLATION WARNINGS and CAUTION: Shock or fire hazards. Possible patient skin burns and ineffective energy delivery. Possible device failure, damage, inability to deliver therapy, shutdown, loss of power during patient care, improper device performance. Possible electrical interference with device performance or with other equipment. Safety risk. Failure to detect change in ECG rhythm. Possible failure to detect out of range condition. Possible interference with implanted electrical device. Possible paddle damage. Possible incorrect energy delivery. CPR METRONOME WARNING: CPR delivered when not needed. SYNCHRONIZED CARDIOVERSION WARNING: Possible lethal arrhythmia. NONINVASIVE PACING WARNING: Possible inability to pace, interruption of therapy, ineffective pacing, and patient skin burns. PEDIATRIC ECG MONITORING AND MANUAL MODE THERAPY: Possible patient skin burns. AED WARNINGS: Possible misinterpretation of data or ECG misinterpretation. Pediatric patient safety risk. ECG MONITORING WARNING: Possible misinterpretation of ECG data. 12-LEAD ECG WARNINGS: Possible inability to obtain diagnostic quality 12-lead ECG or inaccurate diagnosis. Possible incorrect treatment with reperfusion therapy. SPO2, SPCO, AND SPMET WARNINGS AND CAUTION: Shock or burn hazard. Inaccurate pulse oximeter readings. Possible skin injury. Possible strangulation. Inaccurate SPO2, SPCO and/or SPMET readings. Possible equipment damage. NIBP MONITORING WARNINGS AND CAUTION: Possible loss of IV access and inaccurate infusion rate, circulation impairment or inaccurate blood pressure or oxygen saturation readings. Possible patient harm. Equipment damage. ETCO2 MONITORING WARNINGS AND CAUTION: Fire hazard. Possible inaccurate patient assessment or inaccurate CO2 readings. Possible strangulation. Infection hazard. Possible equipment damage. IP MONITORING WARNINGS: Possible inaccurate pressure readings, air embolism, blood loss or loss of sterility. Possible patient injury or equipment damage. Possible lethal arrhythmia. Increased intracranial pressure. TEMPERATURE MONITORING WARNINGS: Possible inaccurate temperature readings. Infection hazard. Possible strangulation. VITAL SIGN/ST SEGMENT TRENDS WARNING: Inaccurate interpretation of patient status.

U.S. Federal law restricts this device to sale by or on the order of a physician.

Please consult Operating Instructions at www.physio-control.com or call 800.442.1142 for complete list of indications, contraindications, warnings, cautions, potential adverse events, safety and effectiveness data, instructions for use and other important information.

GDR 3338691_A