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The HeartSine samaritan® PAD 450P (also known as SAM 450P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: - . Unconscious - Not breathing . - . Without circulation The samaritan® PAD 450P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The samaritan® PAD 450P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 450P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

Like the SAM 350P predicate device, the SAM 450P is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The SAM 450P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. Like the SAM 350P predicate device, the SAM 450P incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation quidelines. However, in addition to the metronome provided in the SAM 350P, the SAM 450P also includes a proprietary impedance cardiogram (ICG) analysis algorithm to determine the rate at which CPR compressions are being administered. The SAM 450P uses the measured CPR compression rate to provide both audible and visual feedback prompts to the user to quide them to administer compressions at a rate within the current AHA resuscitation quidelines (i.e., 100-120 compressions per minute). The SAM 450P's audible and visual feedback prompts take the form of voice prompts such as "Push Faster", "Push Slower", and "Good Speed" and LEDs in red, amber and green being lit on the device cover to indicate if the speed at which the compressions are being delivered is too fast, too slow or within the guideline recommendations. Like the SAM 350P predicate device, the proprietary SAM 450P ECG analysis algorithm automatically determines whether a victim has a shockable or nonshockable rhythm and advises a shock when appropriate. If a shock is required, the SAM 450P will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient. Like the SAM 350P predicate device, an escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation quidelines. After initial analysis and shock delivery (if appropriate), the SAM 450P will advise that CPR may be commenced via a number of voice prompts such as "Begin CPR" and "It is safe to touch the patient" in addition to emitting an audible metronome. Like the SAM 350P predicate device, the SAM 450P records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software. The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the SAM 450P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a paediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft. The Pad-Paks are identical to those cleared under K123881 for the SAM 350P. Like the SAM 350P predicate device, the SAM 450P incorporates the following features: - . Controls for Power ON/OFF and Shock - Automated charging at escalating energies of 150J, 150J, 200J ● - Automated self-tests and LED status indicator ● - Combined, disposable battery and electrodes (Pad-Pak™) - Electrode placement guidance voice prompts and LED/icon indicators - CPR voice prompts and metronome ● - Paediatric function for victims between the ages of 1 and 8 years at non-● escalating energy of 50 J - Integral event data recording .

The HeartSine samaritan® PAD 350P (also known as PAD 350P and SAM 350P) is indicated for use on victims of cardiac arrest who are exhibiting the following signs: - . Unconscious - . Not breathing - Without circulation The samaritan® PAD 350P is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The samaritan® PAD 350P is indicated for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with the adult samaritan® Pad-Pak (Pad-Pak-01 or Pad-Pak-07). The samaritan® PAD 350P is indicated for use on children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with the samaritan® Pediatric-Pak (Pad-Pak-02).

The HeartSine samaritan® PAD (Public Access Defibrillator) 350P (also called the SAM 350P) is a small, lightweight portable battery operated Automated External Defibrillator (AED) designed to treat victims of a cardiac arrest. The samaritan® PAD 350P incorporates a simple user interface of voice and text/icon prompts to guide the user in the use of the device. The samaritan® PAD 350P also incorporates an audible metronome to guide the user as to the correct rate at which chest compressions should be administered in accordance with current AHA resuscitation guidelines. A proprietary ECG analysis algorithm automatically determines whether a victim has a shockable or non-shockable rhythm and advises a shock when appropriate. If a shock is required, the samaritan will automatically charge to the appropriate energy level and prompt the user to press the illuminated shock button. This enables the delivery of therapeutic energy to the patient. An escalating, truncated exponential biphasic waveform pulse is delivered to the patient via two disposable defibrillator electrodes. This waveform is known as SCOPE® (Self-compensating Output Pulse Envelope). A 150 Joule, 150 Joule, 200 Joule escalating energy sequence is used in accordance with current AHA resuscitation guidelines. After initial analysis and shock delivery (if appropriate), the PAD 350P will advise that CPR (cardiopulmonary resuscitation) may be commenced via a number of voice prompts such as "It is safe to touch the patient" and "Begin CPR" in addition to emitting an audible metronome. The defibrillator records the patient's electrocardiogram (ECG) and the patient's ICG (Impedance Cardiogram). The ECG can be viewed using HeartSine's Saver EVO® software. The Pad-Pak is a combined battery and electrode unit which is single use. The electrodes used with the samaritan® PAD 350P are two non-sterile, single-use, self-adhesive, conductive gelled defibrillation electrodes. The Pad-Pak is available in three versions: an adult version, a pediatric version, and an adult version meeting FAA temperature, shock and flammability requirements for use on commercial aircraft. The samaritan® PAD 350P incorporates the following features: - . Controls for Power ON/OFF and Shock - Automated charging at escalating energies of 150J, 150J, 200J . - Automated self-tests and LED status indicator . - Combined, disposable battery and electrodes (Pad-Pak™) . - Electrode placement guidance voice prompts and LED/icon indicators . - CPR voice prompts and metronome . - Pediatric function for victims between the ages of 1 and 8 years at non-. escalating energy of 50 J - . Integral event data recording

The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, nonsterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

The HeartSine Samaritan® PAD PAK pads are single use, non-sterile, hydrogel polymer self-adhesive electrode pads. The Samaritan® PAD PAK pads will be used in conjunction with Samaritan® PAD low energy semi-automatic external defibrillator (AED). The pads are sealed in a pouch to prevent drying out and to maintain their integrity throughout the duration of the shelf life.

The HeartSine Samaritan® PAD is indicated for use on victims of cardiac arrest who are exhibiting the following signs: - Unconscious . - Not breathing - Without circulation . The Samaritan® PAD is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samantan® PAD is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® PAD is a small, lightweight portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® PAD incorporates a simple user interface of voice prompts and visual graphic prompts to guide the user. A proprietary analysis algorithm automatically renders a shock or no-shock decision. The Samaritan® PAD analysis algorithm is identical to the Samaritan® AED model which is in commercial distribution and which has been premarket cleared under K023854. The Samaritan® PAD functions identical to the earlier model Samaritan® AED. If a shock is required, the Samaritan® PAD will automatically charge to the appropriate energy level and prompt the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® PAD will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® PAD uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's heart rhythm and, if required, deliver the defibrillation pulse to the patient. The Samaritan® PAD incorporates the following features: - An LED graphic display providing visual graphic prompting to the . user - Automated self tests with an LED flashing status indicator . - Integral event data recording The Samaritan® PAD uses a disposable, non-rechargeable lithium manganese dioxide battery to operate the Samaritan® PAD for a minimum of 3 hours of continuous operation or provide a minimum of 30 - 200 Joule shocks. The disposable battery is housed in a plastic tray with the disposable defibrillation pads. By housing the battery in the same rigid plastic tray as the electrodes, this will greatly assist the end user in keeping the device in a state of readiness. This will also help eliminate the chance that the end user would respond to an incident with a good battery but expired electrodes, as could happen with many other AEDs currently. Event details are recorded internally in the Samaritan® PAD for later retrieval on a computer. 1.5 hours of continuous ECG as well as incident events time stamped are recorded. Event and incident data can be viewed, printed, annotated and forwarded using the HeartSine SAVER software program. The Samaritan® PAD incorporates a USB communication port that allows for downloading event details to the SAVER software program. This USB port also allows for changing language settings for the Samaritan® PAD voice prompts and allows for customizing the factory settings. Samaritan® PAD also incorporates a training module which converts the Samaritan® PAD into a training device. The training module will automatically disable the Samaritan® PAD energy delivery capability. This training module will allow the user to select training scripts, which simulate different rescue and demonstration scenarios.

The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs: - Unconscious . - Not breathing . - Without circulation . The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient. The Samaritan® AED incorporates the following features: - . Backlight LCD display providing text prompts and ECG display - Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J. - Automated self tests with a separate status indicator display . - . Controls for Power On/Off, Shock, Backlight, Contrast & manual override - Integral event data recording incorporated in the removable battery . A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.