Important Disclosure and Safety Information for Medtronic Automated External Defibrillators 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.

Important Disclosure and Safety Information for Medtronic External Defibrillator/Monitor/Pacemaker Systems

Defibrillation

Indications

Defibrillation is indicated for terminating certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

 

Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia. The biphasic defibrillation waveform used in this device has only been clinically tested on adults; it has not been tested on pediatric patients.

 

The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the defibrillator is not intended for use on pediatric patients less than eight years old.

 

Contraindications

Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA) such as idioventricular or ventricular escape rhythms, and in the treatment of asystole.

Noninvasive Pacing

Indications

Noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

 

Contraindications

Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation. Severe hypothermia is a relative contraindication to pacing a patient with bradycardia.

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

12-Lead Electrocardiography

Indications

A 12-lead ECG is useful in the early detection and prompt treatment of patients with acute myocardial infarction. Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the emergency department.

 

Contraindications

None known.

Pulse Oximetry

Indications

A pulse oximeter is a noninvasive device that checks the saturation of oxygen in arterial blood (SpO2). It is indicated for use in any patient who is at risk of developing hypoxemia.

 

Contraindications

None known.

Noninvasive Blood Pressure Monitoring

Indications

Noninvasive blood pressure is indicated for detection in trends of hypertension or hypotension. These include patient conditions indicated by abnormalities in various physiological parameters such as shock, evaluation of perfusion during dysrhythmia, major fluid shifts, evaluation of response to fluid therapy, and titration of vasoactive and cardiotonic drugs. Noninvasive blood pressure monitoring may be useful during ECG monitoring or for post-defibrillation recovery analysis.

 

Contraindications

NIBP monitoring is contraindicated during seizure or when the patient is connected to a heart/lung machine. In shock conditions, the low amplitude of blood pressure waveforms makes it difficult for the monitor to accurately determine the systolic and diastolic pressures.

End-Tidal CO2 (EtCO2) Monitoring

Indications

EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been place successfully.

 

Contraindications

None known.

Invasive Pressure (IP) Monitoring

Indications

The LIFEPAK 12 IP monitor is indicated for use in monitoring arterial, venous, intracranial and other physiological pressures using an invasive catheter system with a compatible transducer.

Warnings and Precautions

Shock hazard.

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

 

Shock hazard.

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

 

Shock or fire hazard.

Do not immerse any portion of this device in water or other fluids. Avoid spilling any fluids on device or accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this device or accessories unless otherwise specified.

 

Possible fire or explosion.

Do not use this device in the presence of flammable gases or anesthetics. Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

 

Possible electrical interference with device performance.

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 EMS radios on and off. Contact Technical Support if assistance is required.

 

Possible electrical interference.

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.

 

Possible device shutdown for the LIFEPAK 12 defibrillator/monitor.

Always have immediate access to a spare, fully charged, properly maintained battery. Replace the battery or connect the defibrillator to ac power when the device displays a low battery warning.

 

Possible defibrillator shutdown for the LIFEPAK 20 defibrillator/monitor.

When operating on battery power, the large current draw required for defibrillator changing may cause the defibrillator to reach shutdown voltage levels with no low battery warning. If the defibrillator shuts down without warning, or if a LOW BATTERY: CONNECT TO AC POWER message appears on the monitor screen, immediately connect the ac power cord to an outlet.

 

Possible improper device performance.

Using other manufacturers' cables, electrodes, or batteries may cause the device to perform improperly and invalidates the safety agency certification. Use only the accessories specified in these Operating Instructions. Possible failure to detect an out of range condition. Reselecting QUICK SET will reset the alarm limits around the patient's current vital sign values. This may be outside the safe range for the patient.

 

Safety risk and possible equipment damage.

Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. Skin burns will also occur due to heating of electrically conductive materials, such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information.

Caution

Possible device damage.

To help prevent component damage, do not mount device near vibration sources such as engine struts and landing gear.

 

Note:

Medtronic Emergency Response Systems devices, electrodes, and cables are latex-free. LIFEPAK external defibrillator/monitor/pacemaker systems are prescription devices.

 

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