Small, Lightweight, Automated AED Offers Innovation and Value
REDMOND, Wash.(BUSINESS WIRE)
(Product Bulletin) Physio-Control
announced today that the company's HeartSine
samaritan PAD 360P (SAM 360P) fully automatic external
defibrillator (AED) is now available for sale in the United States,
having received U.S. Food and Drug Administration (FDA) Premarket
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The HeartSine samaritan PAD 360P fully automated external defibrillator (AED) from Physio-Control is now available for sale in the United States, having received U.S. Food and Drug Administration (FDA) Premarket Approval. The SAM 360P will complement the SAM 350P and SAM 450P, which are currently offered in the United States, by providing users with a choice of a fully-automatic device, a semi-automatic device, and a device with integrated real-time CPR rate feedback. (Photo: Business Wire)
HeartSine, acquired by Physio-Control in 2015, is the first to receive
approval for a new AED product under the FDA PMA regulatory process,
which is the most stringent for medical devices in the United States and
is a new FDA regulatory requirement for the AED industry.
As part of our diverse portfolio of AED offerings, the SAM 360P is an
intuitive, compact and cost-effective device that assists caregivers
whether at a business, care facility, or a public place in delivering
potentially lifesaving defibrillation in cases of sudden cardiac
arrest, said Ryan Landon, Physio-Control VP/GM, Workplace and Community.
The SAM 360P will complement the SAM 350P and SAM 450P, which also have
FDA PMA and are offered in the United States, by providing users with a
choice of a fully automatic device, a semi-automatic device, and a
device with integrated real-time cardiopulmonary resuscitation (CPR)
The Physio-Control HeartSine samaritan PAD 360P analyzes the cardiac
rhythm and automatically delivers an electrical shock to a victim of
sudden cardiac arrest in order to restore the heart to normal rhythm.
This user-friendly AED provides easy-to-follow visual and audio prompts,
including CPR coaching which verbally guides the rescuer through the CPR
process. Shock delivery, if required, is fully automatic which means
there is no shock button to press.
With a durability rating of IP56, Physio-Control HeartSine AEDs provide
the highest level of dust and water ingress protection in the industry,
making the device well suited to a variety of usage locations
including places where exposure to the elements presents a challenge.
All Physio-Control HeartSine AED models use the company's
interchangeable Pad-Pak? cartridge, which has also received PMA
approval. With a single expiration date for both battery and electrodes,
the expense of tracking and maintaining accessories with different
expiration dates is eliminated. In addition, the Pad-Pak features a
rapid replacement mechanism that enables the battery and pads to be
replaced easily in seconds.
Along with the SAM 360P, Physio-Control will offer a new HeartSine
samaritan PAD Trainer that simplifies CPR and AED training. The new
samaritan PAD 360P Trainer guides users through simulated analyses,
simulated energy delivery and prompted CPR intervals with a training
device which looks like a SAM 360P, is cost effective, and does not
deliver defibrillation shocks.
Physio-Control, now part of Stryker, is the world's leading provider of
professional emergency medical response solutions that predict or
intervene in life-threatening emergencies. The company's products
include LIFEPAK monitor/defibrillators and automated
external defibrillators, LUCAS chest compression systems,
the LIFENET System, HeartSine AEDs and more.
Learn more about HeartSine AEDs at www.heartsine.com.
BRIEF SUMMARY OF INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications for Use: The HeartSine samaritan PAD SAM 350P (SAM 350P),
HeartSine samaritan PAD SAM 360P (SAM 360P) and HeartSine samaritan PAD
SAM 450P (SAM 450P) are indicated for use on victims of cardiac arrest
who are exhibiting the following signs: unconscious, not breathing,
without circulation (without a pulse). The devices are intended for use
by personnel who have been trained in their operation. Users should have
received training in basic life support/AED, advanced life support or a
physician-authorized emergency medical response training program. The
devices are indicated for use on patients greater than 8 years old or
over 55 lbs/25 kg when used with the adult Pad-Pak? (Pad-Pak-01 or
Pad-Pak-07). They are indicated for use on children between 1 and 8
years of age or up to 55 lbs/25 kg when used with the Pediatric-Pak?
Contraindication: If the patient is responsive or conscious, do not use
the samaritan PAD to provide treatment.
Warnings: The samaritan PAD delivers therapeutic electrical shocks that
can cause serious harm to either users or bystanders. Take care to
ensure that no one touches the patient when a shock is to be delivered.
? Touching the patient during the analysis phase of treatment can cause
interference with the diagnostic process. Avoid contact with the patient
while the samaritan PAD is analyzing the patient. The device will
instruct you when it is safe to touch the patient. ? Do not delay
treatment trying to find out the patient's exact age and weight. If a
Pediatric-Pak or an alternative suitable defibrillator is not available,
you may use an adult Pad-Pak. ? The SAM 360P is a fully automatic
defibrillator. When required, it will deliver a shock to the patient
WITHOUT user intervention. ? The SAM 450P CPR Rate Advisor is currently
only intended to provide feedback on adult patients. If you treat a
pediatric patient with the SAM 450P and an adult Pad-Pak, ignore any
voice prompts regarding the rate of CPR. ? Do NOT use the samaritan PAD
in the vicinity of explosive gases, including flammable anesthetics or
concentrated oxygen. ? Do NOT open or repair the device under any
circumstances as there could be danger of electric shock. If damage is
suspected, immediately replace the samaritan PAD. ? The Pediatric-Pak
contains a magnetic component (surface strength 6500 gauss). Avoid
storage next to magnetically sensitive storage media. ? Do not use if
the gel is dry.
Precautions: Proper placement of the samaritan PAD electrode pads is
critical. Electrode pads must be at least 1 in/2.5 cm apart and should
never touch one another. ? Do not use electrode pads if pouch is not
sealed. ? Check the device periodically in accordance with the service
and maintenance instructions provided in the User Manual. ? Operate the
samaritan PAD at least 6 feet/2 meters away from all radio frequency
devices or switch off any equipment causing interference. ? Use of the
device outside the operating and storage ranges specified in the User
Manual may cause the device to malfunction or reduce the shelf life of
the Pad-Pak. ? Do not immerse any part of the samaritan PAD in water or
any type of fluid. ? Do not turn on the device unnecessarily as this may
reduce the standby life of the device. ? Do not use any unauthorized
accessories with the device as the samaritan PAD may malfunction if
non-approved accessories are used. ? Dispose of the device in accordance
with national or local regulations. ? Check with the relevant local
government health department for information about any requirements
associated with ownership and use of a defibrillator in the region where
it is to be used. ? Check expiration date.
Potential Adverse Effects: The potential adverse effects (e.g.,
complications) associated with the use of an automated external
defibrillator include, but are not limited to, the following: ? Failure
to identify shockable arrhythmia. ? Failure to deliver a defibrillation
shock in the presence of VF or pulseless VT, which may result in death
or permanent injury. ? Inappropriate energy which could cause failed
defibrillation or post-shock dysfunction. ? Myocardial damage. ? Fire
hazard in the presence of high oxygen concentration or flammable
anesthetic agents. ? 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 the electrode placement area. ? Allergic dermatitis due to
sensitivity to materials used in electrode construction. ? Minor skin
Caution: U.S. Federal law restricts this device to sale by or on the
order of a physician.
Please consult the User Manual at www.heartsine.com
for the complete list of indications, warnings, precautions, potential
adverse events, safety and effectiveness data, instructions for use and
other important information.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170419005206/en/
Matt Fikse, +1 425-876-4208