LIFEPAK 1000 defibrillator
Brief summary of indications and important safety information
INDICATIONS FOR USE
DEFIBRILLATION The LIFEPAK 1000 is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. LIFEPAK 1000 may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). LIFEPAK 1000 may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes. ECG MONITORING is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring. CONTRAINDICATIONS: None.
OPERATOR CONSIDERATIONS: LIFEPAK 1000 requires operator interaction to defibrillate patient. It is intended for use by personnel who are authorized by a physician or medical director and have, at a minimum, the following skills and training: CPR training, defibrillator training equivalent to that recommended by American Heart Association, and training in use of defibrillator. LIFEPAK 1000 is intended for use in hospital and out-of-hospital environments. Manual mode is intended for use by personnel trained in ECG recognition who want to use defibrillator to deliver a shock independent of AED mode. Operator has control over charging and delivery of shocks. ECG mode provides a nondiagnostic ECG display and is intended for use by personnel trained in ECG recognition to allow for rhythm and heart rate monitoring using standard ECG electrodes. When in ECG mode, the defibrillator’s shock capability is disabled; however, LIFEPAK 1000 continues to analyze patient’s ECG for potentially shockable rhythm.
GENERAL/DEFIBRILLATION WARNINGS. Shock Hazards: LIFEPAK 1000 delivers up to 360 joules of electrical energy. Unless properly used, this electrical energy may cause serious injury or death. Do not attempt to operate unless thoroughly familiar with operating instructions and function of all controls, indicators, connections, and accessories. Clear everyone away from contact with patient, bed, and other conductive material before discharging defibrillator. When discharging defibrillator, do not touch electrodes. Do not immerse defibrillator in water or other fluids. Avoid spilling fluids on device or accessories. Do not disassemble defibrillator or its batteries. Contact authorized service personnel for repair. Possible skin burns and ineffective energy delivery: Dried out or damaged electrodes may cause electrical arcing and patient skin burns during defibrillation. Do not use electrodes that have been removed from foil package for >24 hours or expired electrodes. Check that electrode adhesive is intact and undamaged. Possible misinterpretation of ECG data: Do not analyze in a moving vehicle or move the AED during analysis. Motion artifact may affect ECG signal resulting in inappropriate shock or no shock advised message. Motion detection may delay analysis. Stop vehicle. Do not touch the patient or the AED during analysis.
Excessive Energy Delivery (AED mode): Do not use Pediatric QUIK-COMBO electrodes; these electrodes do not attenuate the energy delivery by LIFEPAK 1000. Implanted electrical devices: Defibrillation may interfere with implanted devices and cause them to malfunction. Place therapy electrodes away from implanted devices if possible. Possible defibrillator shutdown: Always have access to spare, fully-charged, properly maintained battery to avoid possible device shutdown without warning. Replace battery when LIFEPAK 1000 displays warning of REPLACE BATTERY. Possible device failure: Do not modify LIFEPAK 1000 or its batteries. Possible explosion, fire, noxious gas or burns: Do not use device 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. Possible electrical interference or improper device performance: Use only parts and accessories specified by Physio-Control or Stryker. Using other manufacturers’ accessories may affect performance of device or equipment in close proximity and may invalidate safety agency certification. Defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers which may affect performance of equipment operating in close proximity. Equipment operating in close proximity may emit strong EMI or radio frequency interference (RFI) which could affect performance of device. Recommended distances of equipment provided in Operating Instructions. Safety risk and possible equipment damage. Keep AED away from magnetic resonance imaging (MRI) equipment as it is unsafe. ECG MONITORING (ECG mode) WARNINGS. Possible delay in therapy: Do not attempt to connect 3-wire ECG cable to QUIK-COMBO therapy cable or any other AED. ECG cable is functional only with LIFEPAK 1000. Possible misinterpretation of ECG data: Frequency response of screen intended only for basic ECG rhythm identification; it does not provide resolution required for pacemaker pulse visibility, accurate measurements, such as QRS duration, and ST segment interpretation. For such purposes, use ECG monitors with appropriate frequency response.
GENERAL CAUTION: Possible equipment damage: Before using LIFEPAK 1000 disconnect all equipment that is not defibrillator-protected from patient.
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.