Emergency Care


Brief summary of indications and important safety information

INDICATIONS FOR USE: LIFEPAK CR2 AED is indicated for use on patients 1 year of age or older in cardiopulmonary 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). cprCOACH Feedback Technology in CR2 AED is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with AHA Guidelines for patients 1 year of age or older. AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program. The LIFEPAK CR2 Defibrillator is indicated to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery.
CONTRAINDICATIONS: LIFEPAK CR2 AED is not indicated for patients who are conscious and responsive.
DANGER: Do not use LIFEPAK CR2 in presence of flammable gases or anesthetics. WARNINGS: LIFEPAK CR2 AED delivers up to 360 joules of electrical energy. Unless used properly by following AED’s visual and audio prompts, this electrical energy may cause serious injury or death. When instructed EVERYONE CLEAR, do not touch AED, patient, electrode pads or any material/fluid in contact with patient. Make sure no one is touching patient when AED shocks patient. Do not immerse AED in water or other fluids. Avoid spilling fluids on AED or its accessories. Do not store in presence of flammable gases, anesthetics or in direct contact with flammable material. Use care when operating close to oxygen sources. Turn off gas source or move it away from patient during defibrillation. 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. AED should not be used adjacent to or stacked with other equipment. Do not touch patient and USB connector on back of AED simultaneously. Replace battery immediately when AED indicates battery is low. Use only accessories specified by Physio-Control or Stryker. Using other manufacturers’ accessories may cause AED to perform improperly and may invalidate safety agency certification. Contact authorized service personnel for repair. QUIK-STEP electrode pads: Place pads so they adhere to skin completely. Do not allow pads to touch each other or any material on patient’s chest. Do not use damaged, expired, or dried-out pads. Dried out or damaged pads may cause electrical arcing and skin burns during defibrillation. Do not pull red handle to open electrodes until immediately before use. QUIK-STEP electrodes provided with CR2 are not compatible with LIFEPAK 500 device. Emergency medical personnel should not connect these electrodes to LIFEPAK 500 device.
CAUTIONS: Damaged batteries may leak and cause personal injury or equipment damage; handle with extreme care. Do not open device lid unnecessarily as this will reduce internal battery power.
POTENTIAL ADVERSE EFFECTS (for example, complications): Failure to identify shockable arrhythmia. Failure to deliver a defibrillation shock in presence of ventricular fibrillation (VF) or pulseless ventricular tachycardia, 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 electrode pad placement area. Allergic dermatitis due to sensitivity to materials used in electrode construction. Minor skin rash. Fire hazard in presence of high oxygen concentration or flammable anesthetic agents. EMI from 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 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 3339803_A