1. HeartSine samaritan PAD OVERVIEW

2. AGENDA HeartSine Product Family HeartSine samaritan PAD Trainers
Resources
Programs

3. HeartSine Product Family

4. HeartSine AEDs HeartSine samaritan PAD 450P

5. HeartSine samaritan PAD Family
Designed specifically for use in public areas
Feature-rich defibrillators for adult or pediatric use
Lightweight and easy-to-operate
Highest rating for water and dust protection

6. Ready to use anywhere Simple to use Simple to own
HeartSine samaritan PAD 350P
Semi-Automatic
Ready to use anywhere
Simple to use
Simple to own

7. Ready to use anywhere Simple to use Simple to own
HeartSine samaritan PAD 360P
Fully Automatic
HeartSine samaritan PAD 360P
Fully Automatic
Ready to use anywhere
Simple to use
Simple to own

8. Real-time CPR feedback
HeartSine samaritan PAD 450P
with CPR Rate Advisor
Semi-Automatic
HeartSine samaritan PAD 450P
Ready to use anywhere
Simple to use
Simple to own
Real-time CPR feedback

9. Key Messages Ready to use anywhere Simple to own
All HeartSine AEDS are the most compact, and lightweight of all our competitors.
By virtue of the fact that it is the lightest and smallest AND it can be operated without it’s accompanying carry case, this allows the devices to be inserted into first aid kits , making the most portable device on the market.
Its carefully designed PCB layout (and operational management software) makes efficient use of battery-energy and space, without compromising advanced user functionality, all whilst minimising the device weight.
Real-time CPR feedback

10. Smallest & Lightest AED in its Class
Smallest available AED in the U.S. today
Up to 56% smaller than competitive devices
2.4 lbs including pads & battery
Fits anywhere and everywhere…locations:
From constrained to open spaces
From high dust to dust-free
From streams of water to dry land
All HeartSine AEDS are the most compact, and lightweight of all our competitors.
By virtue of the fact that it is the lightest and smallest AND it can be operated without it’s accompanying carry case, this allows the devices to be inserted into first aid kits , making the most portable device on the market.
Its carefully designed PCB layout (and operational management software) makes efficient use of battery-energy and space, without compromising advanced user functionality, all whilst minimising the device weight.

11. Highest Ingress Protection Rating (IP56)
Highest ingress protection rating of any AED for dust and water
Use in the most rugged and unforgiving environments
Particularly ideal for:
Use on maritime vessels
Rescue teams who operate in inclement weather
Areas with heavy dust
This allows our defibrillators to be used in the most rugged and unforgiving environments. This is the actual test that is performed on the device. A Jet of water is blasted at the deivce for a period of 3 minutes, before confirming it is still operational.
Our AEDs are up to the challenge of being used in the harshest of environments

12. Clinically Validated Technology
SCOPE™ Biphasic Technology
Self-Compensating Output Pulse Envelope (SCOPE)
Escalating low-energy waveform
Automatically adjusts for differences in patient impedance to optimize energy delivery, if necessary
This allows our defibrillators to be used in the most rugged and unforgiving environments. This is the actual test that is performed on the device. A Jet of water is blasted at the deivce for a period of 3 minutes, before confirming it is still operational.
Our AEDs are up to the challenge of being used in the harshest of environments

13. Key messages Ready to use anywhere Simple to own
All HeartSine AEDS are the most compact, and lightweight of all our competitors.
By virtue of the fact that it is the lightest and smallest AND it can be operated without it’s accompanying carry case, this allows the devices to be inserted into first aid kits , making the most portable device on the market.
Its carefully designed PCB layout (and operational management software) makes efficient use of battery-energy and space, without compromising advanced user functionality, all whilst minimising the device weight.
Real-time CPR feedback

14. HeartSine samaritan Pad-Pak™
Superior electrode design
Silver/chloride combination inside each pad for extended life
Superior impedance range
Broader range of therapy to all patients
Compatibility
Use across all HeartSine AEDs
Adult and pediatric
Pad-Pak and Pediatric-Pak™
Airline-certified Pad-Pak
ETSO/TSO-certified

15. HeartSine samaritan Pad-Pak Benefits
Two parts, one expiration date
Combines battery and electrode pads in a single-use cartridge
Easy installation
Simply slide in until you hear a “click” and the system is ready to use
Four-year life
One expiration date means one simple maintenance change every for years and one item to monitor and inventory
Ideal for post-sale maintenance from customer point of view
Each replacement means fresh pads and battery that will last 4 years

16. Low Cost of Ownership Initial cost-effective purchase price
On-going maintenance
Four-year Pad-Pak
Combined electrodes and battery in single cartridge

17. Key Messages Ready to use anywhere Simple to own
All HeartSine AEDS are the most compact, and lightweight of all our competitors.
By virtue of the fact that it is the lightest and smallest AND it can be operated without it’s accompanying carry case, this allows the devices to be inserted into first aid kits , making the most portable device on the market.
Its carefully designed PCB layout (and operational management software) makes efficient use of battery-energy and space, without compromising advanced user functionality, all whilst minimising the device weight.
Real-time CPR rate feedback

18. HeartSine samaritan PAD 450P with Integrated CPR Rate Advisor
Real-time CPR feedback
“Begin CPR.”
“Push faster.”
“Push slower.”
“Good speed.”

19. Visual Rate Feedback Voice Prompt LEDs Rate (CPM) Push faster. <90
None
Good speed.
Push slower.
>130

20. Chain of Survival This is universally known as The Chain of Survival.
In the event of SCA, what saves a life is ultimately a combination of steps that must all be executed in order to maximize patient survival.
This is universally known as The Chain of Survival.

21. Chain of Survival Chain of Survival1
Early recognition and activation of emergency response system 2
Early and effective CPR with a focus on chest compressions 3
Rapid defibrillation 4
Effective advanced life support 5
Integrated post-cardiac arrest care

22. Chain of Survival
Any one break drastically reduces chance of survival and recovery from SCA

23. Chain of Survival SAM 450P directly focuses on first three links:1
Early recognition and activation of emergency response system 2
Early and effective CPR with a focus on chest compressions 3
Rapid defibrillation

24. When a Shock is Not Enough…
What happens if you have an AED and the patient has a non-shockable rhythm?
Pulseless Electrical Activity (PEA) or asystole or a non- shockable rhythm?
CPR is the most important treatment they can be given until EMS arrives: it is a key link in the Chain of Survival

25. Post Market Events Returned with Presenting Arrhythmias
95%
Approx 45% require a shock; BUT approx. 95% ALL REQUIRE CPR
Slide 53 – This is internal HeartSine Post-market data – it is not published data, it is merely observational data that we have collected from the from the field. As such it represents data gathered specifically to HeartSine.
this is data that HeartSine has received back from the field. I will make it clear that this what we have seen from the field (clinical studies vary dramatically in the reporting of presenting arrhythmias which is why I reference in-house data here). This data has not been published as of yet, but it is meant to reflect what we have observed from our own in-field data.
No Treatment Needed
Treatable with CPR
Treatable with AED (and CPR)

26. Effective CPR
Improvements in any one of these improves the effectiveness of CPR
But…
The more components you improve, the effect is MULTIPLIED
SAM 450P
Hand position 
CPR fraction
Compression rate
Compression depth
Chest recoil
Ventilations
Compression rate, depth and CPR fraction are the 3 most commonly components emphasised by ERC and AHA to focus on when performing CPR
In patients with OHCA, survival with a good neurological outcome is dependent upon the generation of blood flow to the heart and brain during resuscitation. Berg RA, Sanders AB, Kern KB, et al. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation 2001;104(20):2465—70.
The components of CPR and the combined benefits - Demetris Yannopoulos, Tom P. Aufderheide, Benjamin S. Abella, Sue Duval, Ralph J. Frascone, Jeffrey M. Goodloe, Brian D. Mahoney, Vinay M. Nadkarni, Henry R. Halperin, Robert O’Connor, Ahamed H. Idris, Lance B. Becker, Paul E. Pepe, Quality of CPR: An important effect modifier in cardiac arrest clinical outcomes and intervention effectiveness trials, Resuscitation, Volume 94, September 2015, Pages
Grunau BE, Reynolds JC, Scheuermeyer FX, Stenstrom R, Pennington S, Cheung C, Li J, Habibi M, Ramanathan K, Barbic D, Christenson J, Comparing the Prognosis of those with initial Shockable and Non-Shockable Rhythms with Increasing Durations of CPR: Informing Minimum Durations of Resuscitation, Resuscitation (2016) – In Press – Manuscript attached
Soar et al: Part 4: Advanced life support: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations, Resuscitation, Volume 95, October 2015, Pages e71-e120,
Perkins et al, European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation, Resuscitation, Volume 95, October 2015, Pages 81-99

27. Side-by-Side Comparison
Feature
SAM 450P
SAM 360P
SAM 350P
Shock delivery
Semi-automatic
Fully automatic
Simple operation
2-button
1-button
Real-time CPR rate feedback 
IP56 (Highest)
Integrated battery/electrode for one-change maintenance
4-year electrode/battery life
Pre-connected electrodes
Low escalating energy protocol (SCOPE™)
Operating impedance range of 20 – 230 ohms
The main visual difference between the SAM 350P and 360P is that there is no shock button. During the analysis the device will advise “ Stop CPR, do not touch the patient. Analyzing, do not touch the patient”
If a shockable rhythm is detected it will announce “Shock advised, do not touch the patient. Shock will be delivered in 3….2….1…..(Shocks). Shock delivered, it is safe to touch the patient etc.

28. Side-by-Side Comparison
Feature
SAM 450P
SAM 360P
SAM 350P
Audible and visual prompts/metronome 
Compact, portable and lightweight (2.4 lbs)
Pediatric compatible
90-minute ECG recording time
Automatic self test
Field upgradeable software
Carry case included
Warranty
8 years
Low total cost of ownership (purchase + maintenance)
The main visual difference between the SAM 350P and 360P is that there is no shock button. During the analysis the device will advise “ Stop CPR, do not touch the patient. Analyzing, do not touch the patient”
If a shockable rhythm is detected it will announce “Shock advised, do not touch the patient. Shock will be delivered in 3….2….1…..(Shocks). Shock delivered, it is safe to touch the patient etc.

29. In the box HeartSine samaritan PAD defibrillator One adult Pad-Pak
Carry case
Printed user manual
Warranty card
Pre-paid prescription form

30. Accessories
Pediatric-Pak™
USB Data Cable
Prep Kit

31. Accessories
Cabinet
Wall Bracket
AED Sign
Rescue Backpack

32. samaritan PAD Trainers

33. HeartSine samaritan PAD Trainers
One Trainer for each model
SAM 350P Trainer
SAM 450P Trainer
Includes:
Remote control with AAA batteries
Carry case
Trainer-Pak with cable rewind mechanism
3 pairs of electrodes
Power cord (battery charger)
Trainer configuration tool available online
11/10/201811/10/2018

34. HeartSine samaritan PAD Trainers
Six scenarios
Rechargeable battery
7 hours on single charge
Recharges in 6 hours
User programmable languages
SAM 450P with CPR Rate Advisor
Push faster
Push slower
Good speed
Begin CPR
11/10/201811/10/2018

35. Resources

36. Resources User Material In Box User Material on Site Videos
User Manual (Device and Trainer)
Pad-Pak User Guide
Pediatric-Pak User Guide
User Material on Site
Device and Trainer User Manuals (English and Spanish)
Saver EVO User Manual
Videos
SAM 450P How to Setup, Use and Maintain
SAM 360P How to Setup, Use and Maintain
SAM 350P How to Setup, Use and Maintain
CPR Rate Advisor

37. HeartSine Partner Web Portal

38. Programs

39. Free Pad-Pak Program
Available after every SCA when HeartSine AED is used
Some restrictions apply
Goal to obtain event data for measurement & product improvement
“Tell Us” stickers promote this activity

40. Free Pad-Pak Program Steps to Obtain Free Pad-Pak
Customer or distributor contacts Physio-Control about event and outcome
Customer or distributor submits Saver EVO™ file AND Customer Event form
Event is qualified/approved through clinical team
Physio-Control sends free Pad-Pak

41. Forward Hearts
“Pay it Forward” program to celebrate a life saved by a HeartSine AED
AED donation made on behalf of survivor, distributor & Physio-Control

42. Forward Hearts
Requires Forward Hearts form (on-line or hard copy) and Saver EVO file
Qualifying event
Survivors only

43. WE APPRECIATE YOUR ATTENDANCE
Thank You
WE APPRECIATE YOUR ATTENDANCE

44. 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™ (Pad-Pak-02).
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.  Not for use on patients under 1 year old. Pediatric-Pak for use with children up to the age of 8 years or up to 55 lbs (25 kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.  Only samaritan PADs with the label are suitable for use with the Pediatric-Pak. If the samaritan PAD you are using does not have this label, use the adult Pad-Pak if no alternatives are available.  The use of the Pediatric-Pak will enable delivery of 50 J shocks to the pediatric patient.  The Pediatric-Pak contains a magnetic component (surface strength 6500 gauss).  Avoid storage next to magnetically-sensitive storage media. It is advised that Pediatric-Paks are stored separately when not in use.  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.  Never charge, short circuit, puncture, deform, incinerate, heat above 85ºC or expose contents to water. Remove when discharged.
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 rash.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Please consult the User Manual at for the complete list of indications, warnings, precautions, potential adverse events, safety and effectiveness data, instructions for use and other important information.