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Important Disclosure and Safety Information

LIFEPAK automated external defibrillators (AEDs) are prescription devices.

Indications

Medtronic automated external defibrillators (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). With Infant/Child Reduced Energy Electrodes, the LIFEPAK CR Plus and specially configured LIFEPAK 500 AEDs may be used on children up to 8 years old or 25 kg (55lb).

Contraindications

None known.

Warnings and Precautions

Do not attempt to operate this device unless thoroughly familiar with the Operating Instructions, and the function of all controls, indicators, connections, and accessories. The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in the Operating Instructions, this electrical energy may cause serious injury or death.

Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present and could result in a shock hazard. Contact authorized service personnel for repair.

Do not immerse any portion of this device in water or other fluids. This may create a shock hazard. Avoid spilling any fluids on device or accessories. Do not clean with ketones or other flammable agents. Do not sterilize this device or accessories unless otherwise specified.

Periodically inspect the defibrillator readiness indicator to verify the device is ready for use. Always keep a battery or CHARGE-PAK in the defibrillator and replace the battery or CHARGE-PAK as indicated by the defibrillator.

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI), which could affect the performance of this device. RFI may result in distorted ECG and failure to detect a shockable rhythm. Avoid operating device near cauterizers, diathermy equipment, or cellular phones. Maintain equipment separation of at least four feet and do not rapidly key two-way radios on and off. Contact Technical Support if assistance is required.

This defibrillator may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. Verify the effects of defibrillator discharge on other equipment prior to using defibrillator in an emergency situation, if possible.

Note

Medtronic Emergency Response Systems devices, electrodes, and cables are latex-free.


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Important disclosure and safety information

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