16
4.2
Intended use including intended user and patients
The Heart Guardian HR-501 is a device that automatically analyzes the heart rhythm in
victims of cardiac arrest, and delivers an electrical shock to the heart to restore its normal
rhythm.
The Heart Guardian HR-501 is intended by personnel who have been trained in its
operation. Intended users should have received training in basic life support / AED,
advanced life support or a physician-authorized emergency medical response training
program.
The Heart Guardian HR-501 is indicated for use with electric pads (on patients greater than
8 years old or over 25 kg when used with the adult mode and/or on patients between 1 and
8 years of age or up to 25 kg when used with the child mode).
Heart Guardian HR-501 may be used for both adult and child with the identical pads by
separate button setting. Initial default setting is adult mode.
It is highly recommended for every potential user to complete periodic training for CPR
and HR-501 operation. Please contact national/local representative for Heart Guardian
series to find out detailed CPR and AED operating training schedule.
Heart Guardian, HR-501 is an emergency medical device used for patient stops in
breathing lapsed into unconsciousness due to sudden cardiac arrest.
4.2.1
Indications for Use
Use the Heart Guardian HR-501 with P-303 when the patient:
1. is unconscious and unresponsive; or
2. is not breathing normally; or
3. has not a detectable pulse or other signs of circulation.
No response
Unusual or no breath
Not detection of blood
circulation
4.2.2
Contraindications for Use
Do not use the Heart Guardian HR-501 when the patient:
1. is conscious; or
2. is breathing; or
3. has a detectable pulse or other signs of circulation.