The HeartCheck TM PEN Handheld ECG Is your heartbeat slow, fast, or irregular? Are you at risk? Put your heart health in your own hands

Transcription

1 The HeartCheck TM PEN Handheld ECG Is your heartbeat slow, fast, or irregular? our hands Are you at risk? Put your heart health in your own hands

2 The first FDA-Cleared device that can be unlocked to allow consumers and patients to view and print their own ECGs.* putting your heart health in your hands Using the HeartCheck PEN ECG device, you can now take heart readings the moment a symptom is felt. Whether at home, the gym, or at the office, the HeartCheck PEN is portable, easy to use, and takes accurate heart readings anytime in only 30 seconds that can later be shared with a physician or HeartCheck ECG Coordinating Centre. Until now, monitoring this comprehensive would usually require a lengthy visit to a family physician or hospital. Cleared by the Food and Drug Administration (FDA) Compact and easy to use Accurate heart readings in only 30 seconds Stores up to 20 heart rhythms Unlock the PEN to view and print your own ECGs* With SMART Monitoring, ECGs can be monitored remotely by a physician, clinic, or ECG coordinating centre* * The HeartCheck PEN can be unlocked to view your ECG waveform by CardioComm Solutions, Inc under the direction of a physician.

3 Research has shown that regular ECG-based heart screening significantly reduces the risk of sudden cardiac death. Source: JAMA 2006 and Circulation Smart Monitoring Powered by CardioComm Solutions, Inc. With HeartCheck SMART Monitoring, you can enjoy the peace of mind of having your heart rhythm analyzed and interpreted by a physician, HeartCheck ECG Coordinating Centre, or both, at any time from anywhere in the world with an internet connection* * The free GEMS TM Home software will need to be installed in order to upload your heart rhythm files containing your ECGs. With the HeartCheck PEN device, it only takes 30 seconds to take a heart reading and the device can store up to 20 heart rhythms. Using a USB cable, simply connect the device to your PC and run the free GEMS Home software to upload your heart rhythm files containing your ECGs to a physician or HeartCheck ECG Coordinating Centre. Once uploaded, a physician, HeartCheck ECG Coordinating Centre*, or both, can instantly view and analyze the results of your ECG and heart rhythm. This allows the physician or Coordinating Centre to identify any potential issues and provide the appropriate response. * Additional fees may apply

4 how it works Cardiac arrhythmias affect more than 5 million Americans, and result in more than 1.2 million hospitalizations and 400,000 deaths each year in the US alone. Source: U.S. Markets for Arrhythmia Management Products Using the HeartCheck PEN device, simply take heart readings the moment you feel any symptoms. Using the USB cable provided, connect the device to your PC and run GEMS Home to upload your heart rhythm files containing your ECGs to a physician or HeartCheck ECG Coordinating Centre. Once uploaded, a physician, HeartCheck ECG Coordinating Centre, or both, will view and analyze the results of your ECG and heart rhythms. The HeartCheck ECG Coordinating Centre or physician will create an ECG report on your heart analysis identifying any potential issues. The report will be made available on your PC through the GEMS Home application. The most common signs or symptoms of an arrhythmia are: GEMS Home is a free, easy-to-use, desktop application. What does your ECG show: Palpitations (feeling that your heart is skipping a beat, fluttering, or beating too hard or fast) Read more about common symptoms on the next page A slow heartbeat An irregular heartbeat Feeling pauses between heartbeats GEMS Home can be downloaded from the HeartCheck website and easily installed on your PC in only a few short moments. Once installed, the GEMS Home application supports multiple users and is readily available for use on your computer at any time. Arrhythmia (irregular heart beat) that can be an indication of the risk of stroke (e.g. atrial fibrillation) or other life threatening events. A heartbeat that s too fast or too slow. Information taken from the National Heart Lung & Blood Institute visit for details A heart block, or abnormal conduction of the electrical activity inside the heart. A dangerous change in electrical activity of the heart as a result of certain medications, example QT interval prolongation.

5 about arrhythmias Information taken from the American Heart Association for more information visit The term arrhythmia refers to any change from the normal sequence of electrical impulses. The electrical impulses may happen too fast, too slowly, or erratically causing the heart to beat too fast, too slowly, or erratically. When the heart doesn t beat properly, it can t pump blood effectively. When the heart doesn t pump blood effectively, the lungs, brain and all other organs can t work properly and may shut down or be damaged. Some types of Arrhythmias Atrial Fibrillation Bradycardia Conduction Disorders Premature contraction Tachycardia Ventricular Fibrillation irregular heart beat too slow heart block early beat too fast life threatening Atrial fibrillation (AF or A-fib) Atrial fibrillation (also called AFib or AF) is a quivering or irregular heartbeat (arrhythmia) that can lead to stroke and other heart-related complications. An estimated 2.7 million Americans are living with AF. Untreated atrial fibrillation doubles the risk of heart-related deaths and causes a 4 5-fold increased risk for stroke Normally, your heart contracts and relaxes to a regular beat. In atrial fibrillation, the upper chambers of the heart (the atria) beat irregularly instead of beating effectively to move blood into the ventricles. About percent of people who have strokes have this heart arrhythmia. 50% of AF patients who experience a stroke, die within one year. Although atrial fibrillation can feel weird and frightening, an attack of AF usually doesn t have harmful consequences by itself. The real danger is the increased risk for stroke. Even when symptoms are not noticeable, AF can increase a person s risks for stroke and related heart problems. If AF is detected, the risk of stoke can be reduced by more than 75% with new and effective medications. Symptoms of Atrial Fibrillation Sometimes people with AF have no symptoms and their condition is only detectable upon physical examination or with an ECG. Still, others may experience one or more of the following symptoms: Rapid and irregular heartbeat Fluttering or thumping in the chest Dizziness Shortness of breath and anxiety Weakness Faintness or confusion Fatigue when exercising Sweating Chest pain or pressure* * Chest pain or pressure is a medical emergency. You may be having a heart attack. Call immediately.

6 specifications 1 Display Specfications Display screen type: Parameter: OLED Heart Rate * ECG option available when unlocked Mechanical Specfications Length: Width: Height: Weight: 130mm 30mm 20mm 110g (with batteries) Technical Specfications Lead Position: Sampling Rate:Measuring Range: Heart Rhythm Bandwidth: Measuring Accuracy: Lead I - Hand lead only 250Hz 30bpm bpm 1Hz - 40 Hz bpm: ± 2bpm bpm: ± 4bpm parts & components 1. Right index finger electrode 2. Left index finger electrode 3. Right thumb electrode 4. Display screen 5. Scroll right button 6. Scroll left button 7. Power / Select button: Use this button to power on the device and/or select a menu item from the display screen 8. Start button: Use this button to start taking a heart measurement 9. Left thumb electrode 10. USB Port: Plug USB cable into this port to connect device to PC 11. Battery cover 12. Clip Accessories Standard Accessories: 2 x AAA Alkaline batteries 1 x Instruction Manual 1 x Quick Operation Guide 1 x Warranty Card 1 x USB cable Data Management Software Power Supply Batteries: Protection type: Degree of protection: Safety: 2 AAA Alkaline batteries Internally powered equipment CF Type IEC Environmental Requirements Operating temperature: Storage temperature: Operating humidity: Storage humidity: Atmospheric pressure: 5 C - 40 C -20 C - 55 C 80%, no condensation 90%, no condensation 80kPa - 106kPa

7 heart health in your hands your heart health in your hands Putting your heart health in your hands rt health in your hands Putting your heart health in your hands Putting your heart health in you for information on the HeartCheck PEN or to learn how to order call 1 (877) or visit Toronto Office Yorkland Road North York, Ontario Canada M2J 0B5 Victoria Office Fort Street Victoria, British Columbia Canada V8V 3K3