LIFEPAK CR Plus and LIFEPAK EXPRESS
Brief summary of indications and important safety informationINDICATIONS FOR USE: LIFEPAK CR Plus and LIFEPAK EXPRESS AEDs are indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). LIFEPAK AEDs are intended for use by personnel who have been trained in their operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program. The AEDs may be used with QUIK-PAK defibrillation pads only on adults and children who are 8 years old or more, or who weigh more than 55 lbs (25 kg). The AEDs may be used on children who are less than 8 years old or weigh less than 55 lbs (25 kg) with Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes. The AEDs may be used with the CHARGE-PAK battery charger.
CONTRAINDICATIONS: Do not use LIFEPAK AEDs when the victim is conscious and responsive.
WARNINGS: AED: LIFEPAK AEDs deliver up to 360 joules of electrical energy. Unless properly used, this electrical energy may cause serious injury or death. Do not attempt to operate AED unless thoroughly familiar with the function of all controls, indicators, connectors, and accessories. When instructed “Do not touch patient,” “Stand by,” or “Everyone clear,” remain still, do not touch AED, patient, defibrillation pads or any material in contact with patient. Make sure no one is touching patient when AED shocks the patient. Performing CPR or otherwise handling or transporting the patient while AED is evaluating the heart rhythm can cause an incorrect or delayed diagnosis. Keep patient as still as possible. Do not immerse AED in water or other fluids. Avoid spilling any fluids on AED or its accessories. Do not use in presence of flammable gases or anesthetics. Use care when operating close to oxygen sources. Turn off gas source or move source away from patient during defibrillation. Contact authorized service personnel for repair. Equipment operating in close proximity may emit strong electromagnetic interference (EMI) or radio frequency interference (RFI) which could affect performance of AED. Keep AED away from magnetic resonance imaging (MRI) equipment as it is unsafe. Always keep a CHARGE-PAK battery charger in AED. Routinely check that AED is ready for use. Replace CHARGE-PAK battery charger and QUIK-PAK defibrillation pads after each use of AED. Insert only CHARGE-PAK battery charger into well of AED. Use only parts and accessories specified by Physio-Control or Stryker. Using other manufacturers’ accessories may cause AED to perform improperly and will invalidate safety agency certification. Using damaged or expired accessories may cause AED to perform improperly and may injure the patient or user. Defibrillation pads: Place defibrillation pads so they adhere to skin completely. Do not allow defibrillation pads to touch each other or any other material on patient’s chest. Do not use damaged, expired, or dried-out defibrillation pads. If you cannot determine a child’s age or weight, or if infant/child electrodes are not available, proceed with QUIK-PAK defibrillation pads.
CAUTIONS: If AED has been damaged, remove from use and contact qualified technician. Do not open device lid unnecessarily as this will reduce the internal battery power.
POTENTIAL ADVERSE EFFECTS (for example, complications): Failure to identify shockable arrhythmia. Failure to deliver a defibrillation shock in the presence of ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT), which may result in death or permanent injury. Inappropriate energy delivery which could cause failed defibrillation or post-shock dysfunction. Myocardial damage. 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 pad placement area. Allergic dermatitis due to sensitivity to materials used in defibrillation pad construction. Minor skin rash. Fire hazard in the presence of high oxygen concentration or flammable anesthetic agents. EMI from the AED impacting other devices especially during charge and energy transfers.
U.S. Federal law restricts this device to sale by or on the order of a physician.
Please consult the Operating Instructions at www.physio-control.com or call 800.442.1142 for the complete list of indications, contraindications, warnings, cautions, potential adverse events, safety and effectiveness data, instructions for use and other important information.