Emergency Care

LIFEPAK 20e defibrillator/monitor with and without CodeManagement Module

Brief summary of indications and important safety information

LIFEPAK 20e defibrillator/monitor is an acute cardiac care response system intended for use by authorized healthcare providers in hospital and clinic settings. It is to be used on one patient at a time. LIFEPAK 20e is intended for use by personnel who have been trained in its operation. AED MODE. INDICATIONS FOR USE: 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, LIFEPAK 20e is not intended for use on pediatric patients less than 8 years old. CONTRAINDICATIONS: None known. OPERATOR CONSIDERATIONS: In AED mode, LIFEPAK 20e is intended for use by personnel authorized by physician/medical director and have, at a minimum, the following: CPR training, AED training equivalent to that recommended by AHA, and training in use of LIFEPAK 20e in AED mode. DEFIBRILLATION THERAPY. INDICATIONS FOR USE: Defibrillation is a recognized means of terminating certain potentially fatal arrhythmias, such as VF and symptomatic VT. Delivery of this energy in synchronized mode is a method for treating AF, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, VT. CONTRAINDICATIONS: Treatment of PEA such as idioventricular or ventricular escape rhythms, and in treatment of asystole. OPERATOR CONSIDERATIONS: LIFEPAK 20e delivers energy through disposable electrodes, standard paddles applied to a patient's chest, or internal paddles applied directly to the patient's heart. Defibrillation is only one aspect of medical care required to resuscitate patient with shockable ECG rhythm. Other supportive measures may include CPR, administration of supplemental oxygen and drug therapy. NONINVASIVE PACING. INDICATIONS FOR USE: For symptomatic bradycardia in patients with pulse. CONTRAINDICATIONS: Treatment of VF and asystole. SPO2 MONITORING. Indications for Use: Pulse oximeter is for use in patient at risk of developing hypoxemia. Contraindications: None known. EtCO2 MONITORING. INDICATIONS FOR USE: To detect the level of expired CO2, 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 rapidly detect whether endotracheal tube has been placed successfully. CONTRAINDICATIONS: None known. LIFEPAK 20e with or without CodeManagement Module – ECG MONITORING: ECG obtained by placing either electrodes or paddles on patient; allows for heart’s electrical activity to be monitored and recorded.

Operating Instructions provide important information to help you operate LIFEPAK 20e and CodeManagement Module. Become familiar with all terms, warnings, and symbols. GENERAL/MANUAL DEFIBRILLATION/PADDLE WARNINGS and CAUTIONS: Shock or fire hazards. Possible explosion. Possible patient skin burns. Possible device or paddle damage. Possible device failure, inability to deliver therapy, ineffective energy delivery, shutdown, or improper device performance. Possible electrical interference with device performance, implanted electrical device or other equipment. Safety risk. Failure to detect change in ECG rhythm. Possible failure to detect out of range condition. AED WARNINGS: Possible misinterpretation of data. Pediatric patient safety risk. ECG MONITORING WARNING: Possible misinterpretation of ECG data. PEDIATRIC ECG MONITORING AND THERAPY PROCEDURES: Possible patient skin burns. SYNCHRONIZED CARDIOVERSION WARNING: Possible lethal arrhythmia. Possible monitor incompatibility. REMOTE SYNCHRONIZATION: Possible lethal arrhythmia. Possible monitor incompatibility. CPR METRONOME WARNING: CPR delivered when not needed. NONINVASIVE PACING WARNINGS: Possible inducement of VF. Possible inability to pace. Possible interruption of therapy. Possible patient skin burns. SPO2 WARNINGS AND CAUTION: Shock or burn hazard. Inaccurate pulse oximeter readings. Skin injury. Possible strangulation. Possible equipment damage. EtCOMONITORING WARNINGS AND CAUTION: Fire hazard. Possible inaccurate patient assessment or inaccurate COreadings. Possible strangulation. Infection hazard. Possible equipment damage. CODEMANAGEMENT MODULE BATTERY WARNING: Possible COmonitoring shutdown. REPLACING/REMOVING ELECTRODES WARNING: Possible cable damage and ineffective energy delivery or loss of monitoring.

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 3338728_A