AED Defibrillator Training in Marin County

HeartSine Technologies Inc. Company History

The importance of providing immediate care in cases of Sudden Cardiac Arrest has been well established over the past four decades.

And HeartSine Technologies Inc. has been a global leader in addressing this critical need.

In 1966, at the request of the Queen, our people developed the first mobile defibrillator, and changed the way the world delivered life saving emergency care.

In the years since, HeartSine has continued to be the leading innovator in moving mobile defibrillation technology forward, introducing the following:

• First truly portable defibrillator in a transport case. • Developing the first proprietary electrode design extending effectiveness to over 3.5 years. • One of the first rechargeable systems. • First fully integrated electrode and battery AED replacement pack. • Highest durability rating of any AED/PAD at IP56. • The first flat-screen displays for mobile defibrillators. • The first to develop impendence mitigating algorithms increasing conversions by 15-17%.

More recently, HeartSine recognized the need for defibrillators which could be used by non-professionals with appropriate training and responded with the smaraitan® PAD (Public Access Defibrillator).

Our legacy of invention and innovation makes defibrillator technology available where it does the most good. At home, work or play its lifesaving, pure and simple!

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A Legacy of Leadership in Mobile Defibrillation Technology

1966 – Under the direction of Professor John Anderson (current Chief Technology Officer and member of the board of directors at HeartSine), the Royal Victoria Hospital (RVH), located in Belfast, Northern Ireland, launches the world’s first mobile coronary care unit which utilizes the world’s first portable defibrillator. The complete apparatus weighs 110 pounds.

1967 – Professor John Anderson works in close association with an American company (American Optical) to develop the world’s first truly portable, battery operated defibrillator, weighing 44 pounds.

1971 – Anderson develops new technology that makes possible a 15 pound portable defibrillator with rechargeable batteries that can deliver up to 70 shocks.

1972 – A new integrated unit, featuring ECG display and event recording, is developed. The device weighs approximately 12 pounds.

1973 – Further material advances allow for a dramatic reduction in weight and the first truly lightweight portable defibrillator for emergency services is developed. The unit weighs approximately 7.5 pounds, significantly lighter than anything else available in the rest of the world.

1980 – Prof. Anderson files of the first patents for automatic recognition of ventricular fibrillation. This algorithm provides the sensitivity and specificity necessary for the development of the first AEDs.

1981 – The first AED is developed in Northern Ireland. The unit includes a flat screen display, read out and recording facilities.

2001 – Following the formation of HeartSine Technologies in 1997, HeartSine develops the Samaritan AED. This device is a lightweight unit with smart battery technology, large screen display and utilizes new SCOPE waveform technology.

2004 – The Samaritan PAD unit is introduced. Weighing only 2.4 pounds, this highly portable unit is the lightest available and utilizes new electrode technology and further waveform improvement.

2006 – HeartSine launches the Samaritan PAD, model 300P, with adult and pediatric capabilities.

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HeartSine samaritan® PAD Public Access Defibrillator

Compact, easy-to-use, lifesaving technology

Sudden Cardiac Arrest (SCA) is a leading cause of death globally. Response time is critical for survival. The HeartSine samaritan® PAD was designed especially for use in public areas by providing a sophisticated defibrillator for adult or pediatric use, inside a lightweight and easy-to-operate system.

Compact in size, long on ability.

Portable and lightweight. The samaritan PAD is lighter (2.4 lbs.) and smaller than other defibrillators.

Durable. The samaritan PAD resists shock and vibration and carries an IP56 Rating, the industry’s highest rating against dust and water. It can be taken and used virtually anywhere, even in the most inclement conditions. It also carries a 7-year unit warranty.

Advanced technology. SCOPETM* Biphasic technology automatically optimizes energy output for each person, and has been reported to provide significantly better performance in removing ventricular fibrillation (VF) by the third shock.**

Real economy for the real world.

Two parts, one expiration date. Pad-PakTM cartridge combines battery and electrode pads, with one expiration date to monitor.

Low cost of ownership. Cartridge typically has a shelf-life of 3.5 years from date of manufacture, offering significant savings over other defibrillators that require separate battery and pad units.

Other AED footprints

samaritan PAD footprint

28–56%

smaller

Pad-PakTM and Pediatric-PakTM, with pre-attached electrodes

2.4 lbs. light

Easy-to-follow visual and verbal guides.

User-friendly. The samaritan PAD features easy-to- understand visual and oral prompts that guide a user through the process.

Two-button operation. Only two buttons, ON and SHOCK, are required, providing straightforward operation.

Always ready. A System Status Ready Indicator flashes to show that the complete system is operational and ready for use. Device automatically runs self check each week.

Visual cues prompt pad placement

Stand clear of the patient

It is safe to touch the patient

Technical Overview

Physical

Size: Weight:

Defibrillator

Waveform:

Energy Selection

Charging Time

New Battery: After 6 discharges:

Patient Analysis System

Method: Sensitivity/Specificity:

Environmental

Operating/Standby Temperature: Temporary Transportation Temperature:

Relative Humidity: Water Resistance: Altitude: Shock:

Vibration:

EMC:

With Pad-PakTM Battery Inserted

8.0 in x 7.25 in x 1.9 in (20cm x 18.4cm x 4.8cm) 2.4 lbs (1,1 kg) including Pad-PakTM Battery

(Self-Compensating Output Pulse Envelope) Biphasic waveform. Optimized biphasic escalating waveform compensates energy, slope and envelope for patient impedance

Radiated Emissions: Electrostatic Discharge RF Immunity: Magnetic Field Immunity: Aircraft:

Falling height:

Event Documentation

Type: Memory Capacity:

Playback Capabilities:

Materials Used

PAD SAM300P:

PAD Cartridge: Housing:

ENSS-11:1999+A2:2001

EN61000-4-3:2001 80MHZ-2.5GHZ (10V/m) EN61000-4-8:2001 (3 A/m) RTCA / DO – 160D: 1997, Section 21 (Category M) TSO-C142/RTCA DO-227

1 meter

Internal memory 45 minutes of ECG (full disclosure) and event/ incident recording Custom USB cable directly connected to PC and SaverTM EVO Windows-based data review software

ABS, Santoprene. Printed circuit board with electronic components. Battery: Lithium Manganese Dioxide ABS – Electrodes: Hydrogel, Silver, Aluminium and Polyester

Pre-configured factory settings for escalating energy are AHA/ERC 2005 Adult 1. Shock 150J

Pediatric

1. Shock 50J

2. Shock

50J

2. Shock 150J

3. Shock 200J 3. Shock 50J

Typically 150J in <8 sec., 200J in < 12 sec. Typically 150J in <8 sec., 200J in < 12 sec.

Evaluates patient’s ECG, signal quality, electrode contact integrity and patient impedance to determine if defibrillation is required Meets ISO 60601-2-4 and AAMI DF80:2003.

0°C to 50°C (+32°F to +122°F)

–10°C to 50°C (14°F to 122°F) for up to two days. Unit must be returned to standby/operating temperature for 24 hours before use. 5% to 95% (non-condensing)

IEC 60529/EN 60529 IP56 0 to 15,000 feet (0 – 4,575 meters) MIL STD 810F Method 516.5, Procedure I (40G’s) MIL STD 810F Method 514.5+ Category 4 Truck Transportation – US Highways Category 7 Aircraft – Jet 737 & General Aviation (Exposure) EN 60601-1-2, Second Edition: 2002

Pad-PakTM– Electrode and Battery Cartridge

Adult Pad-Pak (Pad-Pak-01) and Pediatric Pad-Pak (Pad-Pak-02)

*Self Compensating Output Pulse Envelope technology automatically compensates energy, slope and pulse envelope for the patient. **Efficacy of Distinct Energy Delivery Protocols Comparing Two Biphasic Defibrillators for Cardiac Arrest, Walsh, McClelland, Owens, Anderson, Turner, Adgey; The American Journal of Cardiology, Vol. 94, Aug. 1, 2004

Corporate Headquarters:

HeartSine Technologies, Inc. 121 Friends Lane, Suite 400 Newtown, PA 18940 Tel: (215) 860 8100 Toll-free: (866) 478-7463 Fax: (215) 860 8192

Web: heartsine.com

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner.

Manufacturing Facilities

HeartSine Technologies, Ltd Canberra House, 203 Airport Road West Belfast, Northern Ireland BT3 9ED Tel: +44 (0) 28 9093 9400 Fax:+44 (0) 28 9093 9401

The products described in this brochure all meet the applicable European Medical Directive requirements.

Distributed by:

© March 2010 HeartSine Technologies, Inc. All rights reserved.

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Shelf Life: Weight: Size: Battery Type:

Capacity:

Electrodes:

Placement:

Active Gel Area: Cable Length:

Typically 3.5 years from manufacture date 0.44 lbs (0.2kg) 3.93 in x 5.24 in x .94 in (10cm x 13.3cm x 2.4cm) Lithium Manganese Dioxide (LiMnO2) 18V, 0.8 Amp Hrs >30 shocks at 200J or 6 hours of continuous monitoring Samaritan® disposable defibrillation pads are supplied as standard with each device Anterior-lateral (Adult); Anterior-posterior (Pediatric) 100cm2 3.5 ft (1m)