FCC ID: POOWML-C40 Bluetooth Module

LifeVest Model 4000 Patient Manual Lifecor PN 20B0047 Rev FI Preliminary LifeVest 4000 Patient Manual Restricted sale Effectivity Disclaimer Trademarks Federal (USA) law restricts this device to sale by or on the order of a physician. This manual describes the LifeVest 4000 wearable defibrillator system. Information, operation, specifications, and product appearance may change without notice. Names and data used in examples are fictitious. LifeVest is a registered trademark of ZOLL Medical Corporation in the United States of America. All other product names mentioned herein are the trademarks of their respective owners. Copyright notice Copyright 2009 ZOLL Lifecor Corporation. Patents US patents: 6,681,003; 6,280,461; 6,253,099; 6,169,387; 6,097,982; 6,065,154;

5,944,669; 5,929,601; 5,741,306; 5,078,134; 4,928,690; others pending. Software nonexclusive license The LifeVest device includes certain software (Software). ZOLL Lifecor grants you a nonexclusive license to use the Software solely for diagnostic and treatment purposes as part of use of the LifeVest device. You are prohibited from: (i) reproducing the Software;

(ii) removing or destroying any proprietary markings, copyright notices or other legends which are part of the Software; (iii) modifying or reverse engineering the Software; or

(iv) removing the Software from the LifeVest device. Title to the Software will remain at all times with ZOLL Lifecor. You must keep the Software confidential. Contact information ZOLL Lifecor Corporation 121 Freeport Road Pittsburgh, PA 15238-3495 USA Phone toll free (USA) Fax Web 1-800-543-3267 412-826-9485 www.zoll.lifecor.com Page ii 1-800-543-3267 Contents Contents 1: Introduction.............................................................................................................................1-1 About the LifeVest system......................................................................................................1-1 About this manual...................................................................................................................1-1 Whats in this manual .............................................................................................................1-1 Safety information...................................................................................................................1-2 2: Meet the LifeVest system.......................................................................................................2-1 Components ...........................................................................................................................2-1 Monitor....................................................................................................................................2-2 Garment and electrode belt....................................................................................................2-3 Charger...................................................................................................................................2-4 Monitor touchscreen ...............................................................................................................2-5 Charger touchscreen ..............................................................................................................2-6 Help screens...........................................................................................................................2-7 3: Using the LifeVest...................................................................................................................3-1 Daily routine............................................................................................................................3-1 Normal startup routine............................................................................................................3-3 Taking care of the batteries....................................................................................................3-4 Recording your heart rhythm................................................................................................3-10 Sending data manually.........................................................................................................3-11 Speak options.......................................................................................................................3-14 Airplane mode ......................................................................................................................3-16 System info screens .............................................................................................................3-18 Periodically clean and inspect the system............................................................................3-19 What family members need to know ....................................................................................3-20 When you are finished with the device.................................................................................3-21 4: Taking care of the garment and electrode belt....................................................................4-1 Assembling electrode belt to garment ....................................................................................4-1 Putting on the garment and electrode belt .............................................................................4-5 Connecting and disconnecting the electrode belt...................................................................4-6 Removing when you shower or bathe ....................................................................................4-7 Diassembling the electrode belt and garment........................................................................4-8 Laundering the garment .........................................................................................................4-9 5: Responding to alerts ..............................................................................................................5-1 Types of alerts ........................................................................................................................5-1 Siren .......................................................................................................................................5-2 If you get a treatment..............................................................................................................5-3 Gong.......................................................................................................................................5-4 Belt problem message..........................................................................................................5-10 Check belt message .............................................................................................................5-11 Therapy pad problem message............................................................................................5-12 Add gel..................................................................................................................................5-15 Replace belt..........................................................................................................................5-16 Too much gel........................................................................................................................5-17 Device disabled message.....................................................................................................5-18 Appendix A: Quick charts ......................................................................................................... A-1 Appendix B: Glossary................................................................................................................ B-1 Appendix C: Symbols................................................................................................................ C-1 Index 1-800-543-3267 Page iii LifeVest 4000 Patient Manual This page intentionally left blank. Page iv 1-800-543-3267 Introduction 1: Introduction About the LifeVest system The LifeVest device continuously monitors your heart. If it detects a life threatening rhythm that is too fast, the device delivers treatment to restore normal rhythm. If you are conscious, you can prevent a treatment by using the response buttons when the device alerts you that a treatment is coming. About this manual is for patients who are using the LifeVest wearable defibrillator. This manual:

gives you instructions on the use and care of the device.

is intended to supplement the training you received when you were fitted with the LifeVest device. Whats in this manual Heres how to use this manual:

The next few pages contain safety information.

Meet the LifeVest system tells you about the components, what theyre called, and basically how they work.

How to use the LifeVest device suggests a daily routine, tells you how to use and care for the device, and tells you what to tell your family members.

How to take care of the garment and electrode belt goes into the specific details about how to assemble and put on the garment and electrode belt. This section also covers removing the device when you shower or bathe, and how to launder the garment.

Responding to alerts explains the types of alerts and tells you what to do if you get an alert.

Appendixes include Quick charts, a Glossary, and Symbols. The quick charts are particularly helpful as reminders of how to do things. The glossary defines terms and abbreviations. The list of symbols defines icons on the components, in this manual, and on the packaging.

Use the Index at the back of the manual to find what youre looking for quickly. 1-800-543-3267 Page 1-1 LifeVest 4000 Patient Manual Safety information This information helps you safely operate the LifeVest device. Read and understand these warnings, cautions, and symbols before using the device. Terms used WARNING: Warns you of possible injury or death that can be caused by misuse of the device. This includes device failure that could lead to you being not protected by the device. CAUTION: Advises you of a possible problem with the device. Such problems include damage to the device or other property, or minor injury. Shock hazard

Always wear the LifeVest device and make sure the electrode belt and battery are properly connected to the monitor. The device cannot detect an abnormal rhythm or deliver a treatment if not worn and properly connected.

Do not let another person wear your LifeVest device. Because the device has been programmed to recognize your specific heart rhythm pattern, if it detects an unfamiliar heart rhythm, it may shock that person.

Do not attempt to open the monitor, battery, charger, or electrode belt. This may expose you to high voltage and damage the system. Rescue defibrillation

If you should require conventional defibrillation, a warning label on the garment informs medical personnel to unfasten and lay open the garment, thus removing the front therapy pad from your chest. If the garment remains fastened and connected, the LifeVest device may interfere with the defibrillation, and the conventional defibrillator may damage the device. To help ensure proper operation

Use the LifeVest device only after you understand all training and instructions.

Do not put anything other than the monitor into the holster. The extra weight may pull the electrode belt from the body.

Keep the device out of the reach of children. The device may be damaged by improper handling.

Do not kink the cables. Kinking the cables may damage them and cause the system to malfunction. Page 1-2 1-800-543-3267 Introduction

Do not drop the device. If you do drop one of the device components, inform ZOLL Lifecor immediately.

Do not put foreign objects, such as fingers, paper clips, or hair pins into any connectors or openings.

Protect the device from moisture and extreme sunlight when wearing it outdoors. To protect the device, always wear clothing over the garment and keep the monitor and battery in the holster.

Do not put the monitor, electrode belt, battery, or charger in or near water. Do not bathe or shower while wearing the LifeVest device. Also, before washing the garment and holster, be sure to remove the electrode belt and the monitor.

Do not allow food or liquid to splash or drip on the LifeVest device.

Do not expose the device to direct sunlight, excessive heat, or excessive cold for prolonged periods of time.

Use only the cables, batteries, and accessories specified in this manual. If you use any other items, the system may not operate correctly.

Operate the system within the range of 0C to 50C (32F to 122F), up to 95% relative humidity (non-condensing), and up to 10,000 feet in altitude. Risk of fire

Use appropriate caution in an oxygen-rich environment. As with any defibrillator, there is a risk of sparking during defibrillation. Gel release

The therapy pads should not release gel unless a treatment is about to be given. Gel seepage at any other time indicates a damaged electrode belt. If this occurs, call your device provider immediately. If the therapy pad gel gets into your eyes, flush your eyes immediately with water and contact your physician. Your eyes may become irritated from the gel.

Travel

The LifeVest device has not been tested or approved for use in aircraft. Check with your airline for any special restrictions on using personal electronic equipment when making your flight reservations. 1-800-543-3267 Page 1-3 LifeVest 4000 Patient Manual Electromagnetic interference Many common devices, including motors and electronic equipment, may produce electromagnetic interference, also known as EMI, that can affect the operation of the LifeVest device. The LifeVest device has been tested with a number of common sources of such interference, including cellular telephones, airport security systems, and anti-theft detection systems. This testing, along with clinical trial testing, has demonstrated that in everyday use the LifeVest device is not normally affected by commonly encountered electromagnetic interference. Anti-theft detection systems, also known as electronic article surveillance systems, are often used in department stores and libraries to prevent theft by electronically sensing a special tag on a piece of merchandise when the tag passes through a detector gate. In the USA, these detector gates are commonly located near the doorways. In Europe, the detector gates may be positioned near the checkout areas. To prevent possible interference with the LifeVest device, follow these simple guidelines when passing through airport security gates or anti-theft detection gates:

Walk through the gate at a normal pace.

Avoid lingering near or leaning on the gate. In some occupational and hospital environments, unusually high levels of electromagnetic interference may be encountered. Examples of possible sources of such interference include: communication equipment such as microwave transmitters, arc welding equipment, high voltage transmission lines, electrocautery systems, and electronic muscle stimulators. These environments should be avoided while wearing the LifeVest device. In the unlikely event that electromagnetic interference causes you to receive arrhythmia alarms, hold the response buttons to prevent being shocked and move away from the source of the interference. The LifeVest device should return to normal monitoring mode in approximately 5 seconds. Page 1-4 1-800-543-3267 Introduction Wireless interference The LifeVest can be susceptible to or cause wireless interference. Follow these instructions:

Cell phone use When using a cell phone, keep it at least 8 inches away from the sensing electrodes (the round ones) on the electrode belt. If you experience noise alarms while using a cell phone, move the cell phone away from the electrode belt or stop using the cell phone.

Charger use The charger contains a cell phone for data transmissions. Keep the charger at least 8 inches away from your body to prevent interference. If you experience interference when near the charger, move away from the charger. If you take the charger to a hospital, be sure that the use of cell phones is permitted. If not, do not use the charger while in the hospital. If you need to transmit data, use the wired modem connection.

General precaution If you experience any interference with the LifeVest when in the presence of any other wireless device, move away from the device or stop using it. If you continue to have problems, call ZOLL Lifecor at 1-800-543-3267. FCC regulatory information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. The monitor contains:

FCC-ID POOWML-C40 The charger contains:

FCC-ID POOWML-C40 FCC-ID AU792U05E06800 To comply with FCC RF exposure requirements, a minimum separation distance of 20 centimeters (7.9 inches) must be maintained between the users or bystander's body and the antenna on the charger. When a separation distance of 20 centimeters or more, the charger produces RF exposure that is well below the maximum permissible exposure limits. Changes or modifications to this device not authorized by ZOLL Lifecor could void the RF compliance and negate your authority to operate the device. 1-800-543-3267 Page 1-5 LifeVest 4000 Patient Manual This page intentionally left blank. Page 1-6 1-800-543-3267 2: Meet the LifeVest system Components Meet the LifeVest system Item 1 Monitor 2 Garment and electrode belt 3 Charger 4 Holster Description Main unit of LifeVest system. Connects to electrode belt. Monitors your heart rhythm and delivers defibrillating treatment. See details on page 2-2. Fits around your body and connects to the monitor. See details on page 2-3. Recharges the battery, communicates wirelessly with the monitor, and transmits data for doctor review.See details on page 2-4. Lets you carry around the monitor. 1-800-543-3267 Page 2-1 LifeVest 4000 Patient Manual Monitor For details about operating and caring for the monitor, see section 3. For details about resonding to alerts, see section 5. Item 1 Connector 2 Battery 3 Touchscreen 4 Response buttons Description Connects to electrode belt. Powers the monitor. To recharge the battery, use the charger; see page 2-4. Displays messages about device operation, and allows patient to interact with device. In normal operation, the display is upside-down for reading by the patient who is wearing the device. For more on the monitor touchscreen, see page 2-5. Two buttons, located front and back, that light red when the device senses that your heart is in a rapid life-threatening rhythm. You should, if conscious, press both response buttons to stop from getting a defibrillating treatment. You can press and release the response buttons; you dont have to hold them continuously. Page 2-2 1-800-543-3267 Garment and electrode belt For details on assembling, wearing, and caring for the garment and electrode belt, see section 4. Meet the LifeVest system Item 1 Garment 2 Electrode belt 3 Heart sensors 4 Connector 5 Vibration box 6 Therapy pads Description Worn under your clothing to hold the heart sensors and therapy pads against your chest. Assembles to garment and contains heart sensors, vibration box, and therapy pads. Sense your hearts electrical signal for the monitor. Also called electrodes. Connects to the monitor. Notifies you that the device is preparing to give you a treatment. Deliver a treatment to your heart. 1-800-543-3267 Page 2-3 LifeVest 4000 Patient Manual Charger The charger recharges the battery, communicates wirelessly with the monitor, and transmits data for your doctor to review. The LifeVest system includes two batteries so that the monitor can run continuously on battery power. For details on battery care, see section 3. Item 1 Touchscreen 2 Battery 3 Antenna 4 Power supply 5 Power supply connector 6 Phone jacks Description Displays messages about device operation, and allows patient to interact with device. For more on the charger touchscreen, see page 2-6. Shown charging in charger while other battery is in monitor. Raise the antenna for best reception for transmitting data. Plugs into a standard power outlet to provide power to the charger. Connects the power supply to the charger. Connects the charger to a phone line. Only use if instructed by ZOLL Lifecor. Page 2-4 1-800-543-3267 Meet the LifeVest system Monitor touchscreen Shown below is an example of the monitor screen during normal monitoring. Not all of the symbols, controls, and indicators are shown in this example. Some symbols are shown only at certain times. As situations change, the screen will change to advise you and suggest an action to take. Screens that require you to take some action will have a help screen associated with them. For more on help screens, see page 2-7. For a complete description of how to use the touchscreen in the daily use of the LifeVest, see section 3. Item Patient name Menu button Monitor connected What it means and how to use it Displays your name so you know this device was programmed for you. Tap to display the patient menu, where you can select various options. See details in section 3. Shows that the monitor is connected to the patient and is in normal monitoring mode. Battery level instead of the monitor connected symbol, the electrode belt is not If you see this symbol connected. See details in section 3. Shows amount of charge remaining in battery. Also shows when the battery is discharged or is defective. See details in section 3. 1-800-543-3267 Page 2-5 LifeVest 4000 Patient Manual Charger touchscreen Shown below is an example of what you might see on the charger screen during normal use. Not all of the symbols, controls, and indicators are shown in this example. Some symbols are shown only at certain times. For a complete description of how to use the touchscreen in the daily use of the LifeVest, see section 3. Item Data transfer mode What it means and how to use it Shows how data will be transmitted to your health care provider. You will see one of these symbols:

LifeVest is set up for a wireless connection. The number of bars indicates the signal strength. LifeVest is set up for a wireless connection, but there is no signal. Try relocating the charger to improve the signal. If you continue to see this symbol, call ZOLL Lifecor. Charger communication may not be functioning properly. Charger can still be used to charge battery. Call ZOLL Lifecor. LifeVest is set up for a land line phone. Charger status Menu button Help button Shows what is going on with the charger. If a battery is inserted into the charger, the battery status is shown here. If there is no battery inserted, youll get a message telling you to insert the battery. Tap to display the menu where you can select various options. During normal operation, you can ignore this button. Tap for help related to the charger status being displayed. Page 2-6 1-800-543-3267 Meet the LifeVest system Help screens If you press a help button get a help screen. on any screen on the monitor or charger, youll Shown below is an example of a help screen. Item Help message Translate button Touch to speak X button What it means and how to use it Brief message telling you what to do based on the present condition. Tap to see the help message in the secondary language. When you leave the screen, the display returns to the primary language. This button appears only if a secondary language has been programmed. If the speak option is enabled, touch the message area of the screen to hear the help message. The message will be spoken in the language displayed. The area to press is shown by the dashed line in the example above; the dashed line will not be visible on screen. This feature works only on the monitor, not on the charger. To enable this feature, see section 3. Tap to close the screen. 1-800-543-3267 Page 2-7 LifeVest 4000 Patient Manual This page intentionally left blank. Page 2-8 1-800-543-3267 Using the LifeVest 3: Using the LifeVest Daily routine This is an overview of the steps involved in the daily use of the LifeVest. Some details are found elsewhere in this manual. 1 Wear the assembled electrode belt and garment. For details about assembling the electrode belt and garment, see section 4. 2 Put a fully-charged battery into the monitor and follow the normal startup routine. See page 3-3. 3 Change and recharge the battery every 24 hours. See page 3-4. 1-800-543-3267 Page 3-1 LifeVest 4000 Patient Manual 4 Wear the monitor in its holster. The holster strap is adjustable to give you several options for comfortably wearing the system. 5 Respond to any alerts. See section 5. 6 Completely remove the LifeVest when you shower or bathe. See section 4. 7 Change and wash the garment every 1 or 2 days. Wash only the garment. Do not wash the electrode belt, monitor, or any other accessories. Follow the instructions in section 4 for laundering the garment. Page 3-2 1-800-543-3267 Normal startup routine Using the LifeVest 1 Put a fully-charged battery into the monitor. Make sure the battery is completely inserted. 2 Startup screens appear. 3 When you hear the gong and feel the vibration in your back, press the response buttons. If you do not hear the gong or feel the vibration within 30 seconds, remove the battery. Reinsert the battery and try again. If the monitor still does not operate normally, contact ZOLL Lifecor. 4 The monitor displays your name and battery level. Make sure your name appears on the monitor. If your name does not appear, contact ZOLL Lifecor immediately. During normal monitoring, most of the time the LifeVest displays a dark screen. To see the display, press the response buttons. 1-800-543-3267 Page 3-3 LifeVest 4000 Patient Manual Taking care of the batteries What you need to know

You have two batteries so you can use one while charging the other. Change and recharge batteries every 24 hours.

Recharging the battery can take up to 16 hours.

Place the charger in a safe place where you can leave it plugged in. Keep the second battery in the charger while you use the monitor.

The battery and charger may get warm. This is normal. Place the charger in a well ventilated place.

Use only the batteries and charger supplied with the LifeVest system.

Remove the battery from the monitor whenever youre not wearing the device. For example, when you remove the device to take a shower, be sure to remove the battery first, to ensure the device is not active when you are not wearing it. In the event of a power outage If power is interrupted for any reason, you need to take steps to keep your batteries charged.

Notify your electric company and fire department to let them know you have a medical device that needs power.

Locate a source of backup power if possible, such as a generator. Plug the battery charger into the backup power and charge the spare battery continuously. Change the batteries every 24 hours. If a generator is not available, and you expect power to be out for more than 24 hours, contact ZOLL Lifecor immediately at 1-800-543-3267 to have spare batteries sent to you.

When the power is restored, plug in your charger as normal. Continue charging and changing batteries every 24 hours. Page 3-4 1-800-543-3267 Charger setup Using the LifeVest 1 Place the charger in the room where you sleep, on a nightstand or end table, near a power outlet.

Place the charger so you can easily get to the top of the unit to insert and remove the battery.

The charger can actually be placed anywhere in the house, but we recommend the room where you sleep so it's convenient to use every day. 2 Plug the power supply into the back of the charger, then plug it into a standard power outlet. Make sure the outlet stays on all the time, and is not controlled by a lightswitch. 3 Insert the spare battery into the charger.

Orient the battery with its connector facing the rear of the charger.

Push the battery in firmly.

On the chargers touchscreen, read the battery status. Battery should be charging, charged, or testing.

For details about reading the battery status on the charger, see page 3-9. 1-800-543-3267 Page 3-5 LifeVest 4000 Patient Manual 4 Raise the antenna on the charger. 5 Look for a symbol along the top of the chargers display:

Charger is set up for a cellular network.

Signal strength is shown by the number of bars. The more bars, the better. If you have at least one bar, charger setup is finished.

You may see this signal at power-up until the charger finds a signal. That is normal. If you get this symbol all the time, charger is not getting a signal.

Try relocating the charger to another part of the house in order to get a signal. If the problem continues, call ZOLL Lifecor.

Charger communication may not be functioning properly.

Charger can still be used to charge battery.

Call ZOLL Lifecor.

Charger is set up for a land line phone connection.

Charger functions normally, but uses a land line to transfer data. In this mode, a phone line must be plugged into the back of the charger.

Page 3-6 1-800-543-3267 Change and recharge batteries daily Using the LifeVest While you are wearing the device, change and recharge the batteries every 24 hours. Leave the electrode belt connected during this procedure. 1 Remove the existing battery from the monitor.

You can leave the monitor in the holster with the electrode belt connected.

Open the holster end flap, then push the battery latches and slide the battery out of the monitor. 2 Remove the fully-charged battery from the charger and put it into the monitor.

Push the battery firmly into the monitor until it clicks.

Make sure the battery is fully inserted into the monitor.

Make sure the device follows the startup routine on page 3-3. 1-800-543-3267 Page 3-7 LifeVest 4000 Patient Manual 3 Put the used battery from the monitor into the battery charger.

Orient the battery with its connector facing the rear of the charger.

Push the battery in firmly.

Verify that the battery is being charged.

Read the battery status on the charger. See page 3-9. Charger display dims in the dark When the room gets dark, the charger display gets dim. To return the display to full brightness, either turn on the light in the room or tap the screen. If you want to press a button and the screen is dim, first tap the screen to make it bright. Then tap the button. Page 3-8 1-800-543-3267 Using the LifeVest Battery status indicators Screen shows What it means There is no battery in the charger What to do Insert the battery into the charger. Leave one battery in the charger while you use the other battery. Battery is charging Let the battery charge. This can take up to 4 hours. Battery is fully charged, ready for use in monitor Leave battery in the charger until ready to exchange battery. Battery is being tested Battery has a problem, but still might hold a charge Let the test run, which can take up to 12 hours. Test verifies battery function as part of normal routine. After test, battery will be charged, which can take another 4 hours. So the whole process can take up to 16 hours. If you need to use the battery sooner, remove battery from charger as soon as you see this on the screen. Then put the battery back into the charger to skip the test and charge the battery. The test will be performed the next time the battery is plugged into the charger. The battery may charge, but will take longer than normal. Battery can be used, but should be replaced. Call ZOLL Lifecor. Charger has a problem, and cannot charge the battery. Do not leave a battery in the charger. Battery is not being charged. Remove the battery and reinsert it firmly to try again. Call ZOLL Lifecor. 1-800-543-3267 Page 3-9 LifeVest 4000 Patient Manual Recording your heart rhythm At times, you may want to record your heart rhythm for your doctor to review. Follow this procedure to record your heart rhythm. 1 Hold the response buttons for 3 seconds. 2 Release response buttons when you see the recording indicator and hear a single gong. Page 3-10 1-800-543-3267 Sending data manually If you get this message, you need to send data manually. Call ZOLL Lifecor, then follow along with this procedure. Using the LifeVest 1 Go into the same room where the charger is located. 2 On the monitor, tap the menu button

. 3 Tap Send data. 1-800-543-3267 Page 3-11 LifeVest 4000 Patient Manual 4 On the monitors display, look at the symbol above the charger antenna.

Signal strength is shown by the number of segments. The more segments, the better.

You may see this symbol connection. This is normal. while the device seeks a

If this symbol cannot send data. Press Cancel and try again later. does not go away after several minutes, you 5 When you see at least one green segment on the signal strength symbol tap OK. 6 The monitor shows that data is being sent. Stay near the charger until the transfer is complete. 7 The monitor shows when data transfer is complete. Tap OK. Page 3-12 1-800-543-3267 Using the LifeVest If the monitor is unable to send data, youll get this message. Tap X and try again. If you continue to have a problem sending data, you will get additional instructions from ZOLL Lifecor. 1-800-543-3267 Page 3-13 LifeVest 4000 Patient Manual Speak options There are three speak options associated with the help screens:

Speak when you tap the top of the help screen.

Speak with every help screen.

Dont speak with the help screens. You can also change the volume of these messages. This does not affect the volume of the treatment prompts, which are always delivered at full volume. Screens speak in the language displayed. Follow this procedure to change the speak mode or volume. 1 On the monitor, tap the menu button

. 2 Tap Speak options. 3 Tap Mode until you see the speak mode you want. LifeVest speaks when you tap the top of the screen. LifeVest speaks with every help screen. LifeVest does not speak. Page 3-14 1-800-543-3267 Using the LifeVest 4 Tap Volume until you hear the desired volume. Volume level 1. Volume level 2. Volume level 3. 5 When you are finished with the speak options, tap OK. To close the screen without making any changes, tap X. 1-800-543-3267 Page 3-15 LifeVest 4000 Patient Manual Airplane mode Airplane mode disables the LifeVest from wirelessly transmitting data to avoid interfering with aircraft operation and other electrical equipment. Follow this procedure to set the LifeVest for airplane mode. 1 On the monitor, tap the menu button

. 2 Tap the next page button

. 3 Tap Airplane mode. When the airplane symbol appears on the button, airplane mode is selected. Each time you tap Airplane mode, it toggles between on and off. Airplane mode ON. No signals are transmitted from LifeVest. Airplane mode OFF. This is the normal position. Tap X to save your changes and close this screen. Page 3-16 1-800-543-3267 Using the LifeVest 4 On the home screen, notice the airplane symbol in the upper right corner. That means the LifeVest is in airplane mode. When you see the airplane symbol, no signals will be transmitted from LifeVest. The monitor will go out of airplane mode the next time you change the battery, or if you attempt to manually send data. 1-800-543-3267 Page 3-17 LifeVest 4000 Patient Manual System info screens If you ever call for service or support, you may be asked for information about your LifeVest. You may be instructed to go into the system information screens. 1 On the monitor, tap the menu button

. 2 Tap System info. 3 System information will be shown.

To go from one screen to another, tap the next page

To close either screen, tap X. button. Page 3-18 1-800-543-3267 Using the LifeVest Periodically clean and inspect the system How to clean the garment Specific details about laundering the garment are in section 4. How to clean the non-washable items Unplug the battery charger and disconnect the power cord before cleaning. Non-washable items such as the battery, charger, cables, ECG electrodes, and therapy pads may be cleaned using a soft cloth sparingly dampened with Formula 409 all-purpose cleaner or equivalent cleaning solution. When you clean these items, keep in mind:

Dont apply liquids directly to any of the non-washable items, as they contain electronic components that can be damaged.

Dont attempt to clean any electrical contacts or connectors.

Dont use any cleaning solution on the garment. Inspection Inspect your system periodically. If you should notice any of the following conditions, please notify ZOLL Lifecor as soon as possible:

Cracks in the housing of the monitor, battery, or charger.

Cracks in the therapy pads.

Tears in the garment or holster.

Blue gel leaking from the therapy pads at any time other than when defibrillation is about to occur or has just occurred. 1-800-543-3267 Page 3-19 LifeVest 4000 Patient Manual What family members need to know Who this information is for This information is for the family and friends of the person wearing the LifeVest device. What you need to know Since your family member or friend may be wearing the LifeVest device for a period of time, you may want to understand the daily routine involving the device, as well as warnings and cautions directed to the patient. In that case you should probably read this entire manual. Information for family members Anyone associated with the patient should be aware of the following information:

Dont hold the response buttons for the patient. Only the patient should press the response buttons. The patients ability to press the response buttons lets the device know whether or not the patient is still conscious and is critical in deciding when to give the patient a shock. WARNING: If anyone other than the patient holds the response buttons, needed therapy may not be delivered, possibly resulting in serious injury or death.

Dont touch the patient when a treatment is about to occur. If anyone touches the patient when the patient receives a treatment, the person touching the patient will be shocked.

Dont remove the battery, dont disconnect the electrode belt from the monitor, and dont loosen the garment unless you are prepared to do CPR (cardiopulmonary resuscitation) on the patient.

Dont let anyone else wear the LifeVest device. If someone other than the patient wears the device, it will not recognize the unfamiliar heart rhythm and may shock that person. If the LifeVest shock does not revive the patient and the patient is unconscious, call 911 (or your emergency medical service) and then start CPR.

A label on the front of the garment reminds medical personnel to open the garment before giving the patient conventional external defibrillation.

Keep the LifeVest device out of the reach of children. Page 3-20 1-800-543-3267 Using the LifeVest When you are finished with the device Call ZOLL Lifecor and arrange to return the LifeVest system. In the USA, call 1-800-543-3267. Battery recycling The lithium-ion batteries used with the LifeVest device are recyclable and should be returned to ZOLL Lifecor. WARNINGS:

Do not dispose of the batteries in the trash.

Do not incinerate the batteries since they might explode. 1-800-543-3267 Page 3-21 LifeVest 4000 Patient Manual This page intentionally left blank. Page 3-22 1-800-543-3267 Taking care of the garment and electrode belt 4: Taking care of the garment and electrode belt Assembling electrode belt to garment 1 Lay the electrode belt and garment on a flat surface as shown below.

Place the garment with the blue tabs (shown as item 1 below) on the back pockets facing up.

Place the electrode belt with the white foam sides of the therapy pads

(shown as item 2 below) facing up. 1-800-543-3267 Page 4-1 LifeVest 4000 Patient Manual 2 Insert the rear therapy pads into the garments rear pockets.

Make sure the metal sides of the pads (with the green stickers) face the metallic mesh on the pockets.

Secure by closing the two snaps. 3 Attach the vibration box to the garment.

Position the vibration box with the connector cable exiting down.

Slide the vibration box under the strap along the edge of the garment, with the connector cable going under the strap.

Secure with the attached blue strap. Page 4-2 1-800-543-3267 Taking care of the garment and electrode belt 4 Turn the garment over. Insert the front therapy pad into the front pocket.

Make sure the metal side of the pad (with the green sticker) faces the metal mesh on the pocket.

Once the therapy pad is fully inserted, snap the pocket closed. 5 Attach the ECG electrodes to the garment. Match the colors on the backs of the electrodes to the colors on the garment. 1-800-543-3267 Page 4-3 LifeVest 4000 Patient Manual Assembled electrode belt and garment The assembled electrode belt and garment resembles the following figures. If the straps are not buttoned, button them now. Outside view This side faces away from your body when worn. Inside view This side faces toward your body when worn, with the metallic mesh pockets against your skin. Page 4-4 1-800-543-3267 Taking care of the garment and electrode belt Putting on the garment and electrode belt 1 Before putting on the garment, r emove all clothing and undergarments from your upper body. All underwear and clothing must be worn OVER the device, NOT under it. 2 If desired, apply unscented hand lotion or skin cream to the four ECG (round) electrodes. 3 Put on the garment and connect the garment ends together in the front.

Make sure that the garment doesnt get twisted.

The metal mesh pockets must touch your bare skin in order for a

defibrillating pulse to be delivered. If you are a female, wear a bra OVER the assembled electrode belt and garment. Make sure that the metallic side of the front therapy pad is pressing against your body rather than the underside of your left breast. 4 Look in a mirror to make sure that:

Garment and belt assembly are being worn correctly.

Garment is not twisted.

Electrodes and therapy pads are pressing against bare skin. The metallic mesh pockets and metallic side of the therapy pads (with green stickers) MUST TOUCH YOUR BODY for the device to work properly. 1-800-543-3267 Page 4-5 LifeVest 4000 Patient Manual Connecting and disconnecting the electrode belt Normal daily use does not require disconnecting the electrode belt from the monitor. However, if you do need to disconnect the electrode belt, follow this procedure. To disconnect the belt 1 Squeeze the sides of the connector as you pull it away from the monitor. 2 Pull the connector out of the monitor. To connect the belt 1 Line up the connector with the monitor. The cable should be facing toward the center of the monitor. WARNING: Do not force the connector. Allow the connector to align before pushing it in. Forcing the connector may damage it and cause the system to malfunction. 2 Gently push the connector straight in until it locks in place. Page 4-6 1-800-543-3267 Removing when you shower or bathe Taking care of the garment and electrode belt When you remove the device to bathe or shower, you are not protected by the device. Bathe or shower in the evening, preferably when someone else is home with you. When you remove the device for any reason, remove the battery first. When you put the LifeVest device back on, put the battery in last. Completely remove the LifeVest device when you shower or bathe. Dont put the monitor, electrode belt, or battery in or near water. To remove the LifeVest device before you bathe or shower 1 Remove the battery from the monitor. Keep the belt connected to monitor. 2 Unfasten and remove the garment from your body. If you plan to change the garment, follow the procedure on the next page to disassemble the electrode belt from the garment. 1-800-543-3267 Page 4-7 LifeVest 4000 Patient Manual Diassembling the electrode belt and garment 1 Remove electrodes from garment. Pull on the electrodes, not on the wires. 2 Remove the vibration box from the garment. Do not use the vibration box as a handle to pull or lift the electrode belt. Pulling on the vibration box can damage the internal wiring and cause the system to malfunction. 3 Unsnap and remove the therapy pads from their pockets. 4 Wipe the metal surfaces of the electrodes and therapy pads with a soft cloth dampened with rubbing alcohol. 5 Reassemble the garment and electrode belt as described on page 4-1. 6 Put on the assembled garment and electrode belt as described on page 4-5. To launder the dirty garment, see next page. Page 4-8 1-800-543-3267 Laundering the garment Taking care of the garment and electrode belt Launder the garment every 1 or 2 days. Before washing the garment:

Remove the electrode belt to protect it from damage. Do not wash the electrode belt.

Leave the straps buttoned on the garment. Attach the ends of the garment together. Wash the garment by itself. Do not wash it with other laundry. The garment may be hand-washed or machine washed, using a normal wash cycle and warm water, with a maximum water temperature of 45C (113F). Use clothes washing detergent only, such as Woolite Original, Tide, Purex After the Rain, Fab Spring Magic, or Arm &

Hammer for sensitive skin. CAUTION: Do not use chlorine bleach, bleach alternatives, fabric softener, or anti-static sprays. Do not use detergents that include bleach or fabric softener additives. Use a clothes dryer or hang the garment to dry. If you use a clothes dryer, set it to a warm or medium setting. Do not use the high heat setting. 1-800-543-3267 Page 4-9 LifeVest 4000 Patient Manual This page intentionally left blank. Page 4-10 1-800-543-3267 Responding to alerts 5: Responding to alerts Types of alerts How you respond to an alert depends on the type of alert you get. There are three types of alerts:

vibration

siren

gong Vibration Siren Gong If you get a vibration in the back of the electrode belt, you are being warned that youre about to get a siren alert. You will also get a short vibration alert every time you change the battery. Press the response buttons to stop this alert. Follow the same instructions as for the siren alert on page 5-2. The siren is a high-pitched two-tone alarm that means an abnormal rhythm has been detected. Press the response buttons to stop this alert. If you dont respond to this alert, you will probably receive a treatment within the next minute. Follow the instructions on page 5-2. The gong is a low-pitched gong sound that repeats about once a second. This type of alert is accompanied by a message stating a problem that needs your attention. Read the message to see what action needs to be taken. For specific help, press the help button on the screen. Follow the instructions on page 5-4. 1-800-543-3267 Page 5-1 LifeVest 4000 Patient Manual Siren If you are conscious, press the response buttons to stop the treatment from occurring.

The siren stops and a voice prompt alerts bystanders that the treatment has been stopped.

NO ONE ELSE should press the response buttons. Only you, the patient, should press the response buttons. If you feel dizzy, find a place to sit or lie down.

You can press and release the buttons; you dont have to hold them continuously. Press and release the response buttons each time you feel the vibration alert or hear the siren alert. If you are not conscious, naturally you will not be able to press the response buttons.

This allows the device to deliver a treatment.

Voice prompts alert bystanders not to touch you.

Voice prompts also alert bystanders to call an ambulance after you have been given a treatment.

WARNINGS:

If you fail to press the response buttons when you are awake, you may receive a treatment, which will be painful. That is why you need to press the response buttons if you get the siren alert. If you receive a treatment while your heart is beating normally, the treatment may cause an abnormal rhythm to occur. There is a small possibility that the abnormal heart rhythm may not be detected and death may result.

Do not press the response buttons by artificial means or by having another person press them for you. If anyone other than the patient presses the response buttons, needed therapy may not be delivered, possibly resulting in serious injury or death.

Do not remove the battery from the monitor when you get alerts. The device needs to be powered up in order to continue to function. Page 5-2 1-800-543-3267 Responding to alerts If you get a treatment After getting a treatment, you may feel wetness on your back, sides, and chest. This is gel that was released just before the first treatment was delivered. You might also have some chest soreness. When any of these messages appear, tap the help button about what to do. for reminders 1 Call your doctors emergency number immediately to report your treatment. 2 Unless your doctor tells you otherwise, continue to wear the LifeVest system.

Leave the belt connected. Do not remove the electrode belt or garment, and do not disconnect the electrode belt from the monitor.

Leave the battery in the monitor. Do not remove the battery. Continue to change and recharge the batteries as normal.

Leave the gel under the therapy electrodes. Do not wipe them dry.

Tap OK after reading the message. 3 Check the display for any messages and take the action indicated.

For help with specific messages, tap the help button

For general instructions for any message accompanied by a

. gong, see page 5-4. 4 Call ZOLL Lifecor and arrange to get a new belt. Tap OK to resume normal monitoring. 1-800-543-3267 Page 5-3 LifeVest 4000 Patient Manual Gong If you get a gong, there is a problem that needs your attention.

Read the message on the monitors display.

For specific help with any message, tap the help button

Use this chart to see what the message means and what to do.

Some messages refer to additional details located elsewhere in this manual. Message What it means Red battery symbol means that battery has discharged and needs to be changed. What to do Change to a fully-charged battery and place discharged battery into the charger. Tap the battery symbol for helpful reminders. Yellow battery symbol means that battery condition cannot be determined, but battery may continue to function normally. Continue to use and recharge battery as normal. Tap the battery symbol for helpful reminders. Call ZOLL Lifecor. Electrode belt is not connected to monitor. Connect the electrode belt to the monitor. Page 5-4 1-800-543-3267 Message What it means Monitor is receiving a poor signal from the electrode belt. Electrode icons can be any combination of green, yellow, or red to show specific conditions. Tap the help button for details. Monitor is not receiving a clear signal from the electrode belt. Electrodes are probably not in good contact with skin. Electrode icons can be any combination of green, yellow, or red to show specific conditions. Tap the help button for details. Therapy pad is not making contact with your skin. You have received a treatment and the gel is drying out. Responding to alerts What to do Adjust your garment and electrode belt so that each ECG electrode is touching your skin. Pay particular attention to the electrode icons that show yellow or red on screen. Tap OK to return to normal operation. For more details about this message, see page 5-10. Adjust your garment and electrode belt so that each ECG electrode is touching your skin. Pay particular attention to the electrode icons that are yellow or red. Tap OK to return to normal operation. For more details about this message, see page 5-10. Make sure the therapy pads are inserted correctly, with their metal sides (with green stickers) against your skin. Make sure the therapy pads and mesh pockets are pressing against your skin. Tap OK to return to normal operation. For more details, see page 5-12. Add gel to the therapy pads or replace electrode belt. Tap OK to return to normal operation. See details on page 5-15. 1-800-543-3267 Page 5-5 LifeVest 4000 Patient Manual Message What it means System has a problem that requires servicing. You can continue to use the device. Note the code beginning with the number 1. What to do Write down code number and call ZOLL Lifecor. Tap OK to return to normal operation. System has a more severe service problem. You CANNOT use the device. Note the code beginning with the number 2. Write down the code number and call ZOLL Lifecor immediately. Battery has discharged and needs to be changed. Change to a fully-charged battery and place discharged battery into the charger. Tap OK to return to normal operation. After multiple attempts to adjust the belt, monitor is still not receiving a good signal from the electrode belt. See details on page 5-11. Page 5-6 1-800-543-3267 Responding to alerts Message What it means Device is checking to see if the belt is sending a clear signal. What to do No action required. Just wait while this screen is displayed. You have received a treatment. Device has been disabled and is no longer monitoring your heart signal. Continue to wear the LifeVest device. Call your doctors emergency number immediately. Leave the electrode belt connected;

change and recharge the battery as normal until you receive a replacement belt. Follow instructions about what to do after receiving a treatment on page 5-3. Tap OK to return to normal operation. This message is intended to tell bystanders to call an ambulance if you are found unconscious. If you are conscious and you feel OK, follow instructions on page 5-18. The system is performing maintenance on the belt. No action required. Just wait while this screen is displayed. 1-800-543-3267 Page 5-7 LifeVest 4000 Patient Manual Message What it means You are to press the response buttons to test their function every time the battery is installed. What to do At startup, press the response buttons as a reminder of what to do when a siren alert sounds. This message may appear at startup. You may be holding the response buttons instead of pressing and releasing them. Release the response buttons. If you are not holding the response buttons, device may be defective. Call ZOLL Lifecor. This message may appear after a detection. You may be holding the response buttons and you are no longer having a treatable heart rhythm. Release the response buttons. If you are not holding the response buttons, device may be defective. Call ZOLL Lifecor. Data should be sent manually as soon as possible. Either a treatment was delivered or the monitor has data that has not been transmitted for some time. Contact ZOLL Lifecor for instructions about how to send data. Tap OK to return to normal operation. See details in section 3. Page 5-8 1-800-543-3267 Message What it means Too much gel is on your skin. Responding to alerts What to do Leave the gel that is under the therapy pads, but wipe the gel from the skin that is not under the therapy pads. Tap OK to return to normal operation. See details on page 5-17. 1-800-543-3267 Page 5-9 LifeVest 4000 Patient Manual Belt problem message This screen shows which ECG electrodes (the round ones) are causing problems. The symbols help you to determine the problem. You may get any combination of these symbols:

Electrode off skin: Electrode is not making good contact with skin. Poor signal: Could be muscle noise, electrical noise, weak signal, or interference. Good signal: Situation normal, no action required. If you get one or more of the yellow or red symbols, make sure:

The electrodes indicated by the yellow or red symbols are touching your skin.

Nothing is between the ECG electrodes and your skin, such as clothing or one of the cables.

Garment and belt fit snugly, with the electrodes pressing against your skin. While youre wearing the LifeVest, tap the help button for reminders about what to do. Page 5-10 1-800-543-3267 Check belt message Responding to alerts After you get a number of belt problem screens, you may get this message. It means that the monitor is still not receiving a good signal from the electrode belt. If you get this message:

1 Disconnect the electrode belt from the monitor. 2 Take off the garment and make sure that nothing is covering the metal surfaces of the ECG electrodes. 3 Put a dab of unscented hand lotion, skin cream, or moisturizer on the surface of each ECG electrode (the round ones, not on the therapy pads). 4 Put the garment on and connect the electrode belt to the monitor. While youre wearing the LifeVest, tap the help button for reminders about what to do. If problems continue, call ZOLL Lifecor. 1-800-543-3267 Page 5-11 LifeVest 4000 Patient Manual Therapy pad problem message This screen shows when the therapy pads (the large rectangular ones) are causing problems by not making good contact with your skin. The symbols help you to determine the problem:

Therapy pad off skin: Metal side is not making good contact with skin. Therapy pad on skin: Situation normal, no action required. If you get red symbols, make sure:

Therapy pads and mesh pockets are pressing against your skin. For details, see page 5-13.

Therapy pads are inserted correctly into their pockets, with the metal sides (with the green stickers) facing the metal mesh. For details, see page 5-14.

Garment and belt fits snugly, with the metal mesh of the therapy pads pressing against your skin. While youre wearing the LifeVest, tap the help button for reminders about what to do. Page 5-12 1-800-543-3267 Responding to alerts Therapy pad and mesh pocket may not be pressing against your skin 1 Change your body position and make sure that the garment is not twisted or loose. 2 Make sure that the metal mesh pockets and the therapy pads are pressing against your bare skin. For details about putting on the garment and electrode belt, see section 4. 3 To help prevent stretching, launder the garment every 1 or 2 days. Follow the instructions for how to launder the garment in section 4. 4 If problems continue, call ZOLL Lifecor. 1-800-543-3267 Page 5-13 LifeVest 4000 Patient Manual Therapy pad may not be inserted correctly into its pocket 1 Remove the battery from the monitor, then remove the garment and electrode belt from your body. 2 Make sure the therapy pads are inserted correctly, their metal sides (with green stickers) facing the metal mesh, which faces your body. 3 Put on the garment and electrode belt, then put the battery into the monitor to resume normal operation. 4 If problems continue, call ZOLL Lifecor. Page 5-14 1-800-543-3267 Add gel Responding to alerts After you receive a treatment to correct an abnormal rhythm, you may see this message telling you to add gel. Follow the instructions below to add gel. While youre wearing the LifeVest, tap the help button for reminders about what to do. Tap OK to resume normal monitoring. To add gel 1 Remove the battery from the monitor, then remove the electrode belt and garment from your body. 2 Locate the packets of gel you got with the LifeVest system. Add one-half packet of gel to each therapy pad, directly onto the mesh material of each pocket. Apply to the rear pads and the front pad (but not to the ECG electrodes.) 3 Put on the electrode belt and garment. Refer to section 4. 4 Put the battery into the monitor and follow the normal startup routine. 1-800-543-3267 Page 5-15 LifeVest 4000 Patient Manual Replace belt After you receive a treatment to correct an abnormal rhythm, you may see this message telling you to replace the belt. Continue to wear the belt until you get the replacement belt. The belt is still functional and can provide additional treatment if needed. When you receive the new belt, follow the instructions below to replace the belt. While youre wearing the LifeVest, tap the help button for reminders about what to do. Tap OK to resume normal monitoring. To replace the electrode belt 1 Remove the battery from the monitor. 2 Disconnect the electrode belt from the monitor. 3 Remove the electrode belt and garment from your body. 4 Disassemble the electrode belt from the garment, assemble the new electrode into a clean garment, and put on the assembled electrode belt and garment. Refer to section 4. 5 Connect the electrode belt to the monitor. 6 Put the battery into the monitor and follow the normal startup routine. Page 5-16 1-800-543-3267 Too much gel Responding to alerts After you add gel to the electrode belt, you may see this message telling you there is too much gel between the therapy electrodes. Follow the instructions below to remove the excess gel. While youre wearing the LifeVest, tap the help button for reminders about what to do. Tap OK to resume normal monitoring. To remove excess gel 1 Remove the battery from the monitor. 2 With the electrode belt and garment on your body, and using a towel or soft cloth, wipe your skin between the front and back therapy pads on the left side of your body. Be careful not to remove the gel under the therapy pads. 3 Reinstall the battery into the monitor. 1-800-543-3267 Page 5-17 LifeVest 4000 Patient Manual Device disabled message If the LifeVest detects an untreatable condition called asystole, where your heart slows and stops, it will display this message to alert bystanders. Under rare circumstances, it may display this message when your heart has not stopped. If you are conscious and you feel OK and you get this message, follow the instructions below. If you get this message and youre conscious The problem may be with the signal from the ECG electrodes. Follow this procedure to correct the problem. 1 Remove and reinstall the battery. 2 If the message returns, check your electrode belt and garment. Make sure:

All ECG electrodes are touching your skin.

Nothing is between the ECG electrodes and your skin, such as clothing or one of the cables.

Garment and belt fit snugly, with the electrodes pressing against your skin. 3 If you continue to get this message even though you remain conscious, call ZOLL Lifecor. Page 5-18 1-800-543-3267 Appendix A: Quick charts Daily routine Assemble electrode belt and garment Put on LifeVest system Normal startup routine Recharge batteries daily Quick charts Remove LifeVest system before bathing or showering 1-800-543-3267 Page A-1 LifeVest 4000 Patient Manual Change garment as needed Disassemble electrode belt and garment Manually send data to your doctor If you get a treatment Change speak options Airplane mode Page A-2 1-800-543-3267 When youre finished with device If you get an alert Quick charts 1-800-543-3267 Page A-3 LifeVest 4000 Patient Manual Responding to a gong alert This is just a partial list. For complete list and further details, see section 5. Page A-4 1-800-543-3267 Glossary Appendix B: Glossary Arrhythmia Asystole Cardioversion defibrillation ECG electrodes Electrode Electrode belt Abnormal heart rhythm. Heart stops beating. Restoration of normal heart rhythm by electrical treatment. Electrocardiogram electrodes, used to monitor heart rate. A solid electrical conductor through which an electric current enters and leaves a body. The belt that contains the ECG electrodes, the therapy pads, the vibration box, connector, and cables. Electromagnetic interference (EMI) Electrical or magnetic interference caused by sources such as motors, transformers, welding equipment, and speakers, that can interfere with device performance. Fibrillation Garment ICD Joules MI SCA SCD Therapy pads Ventricular fibrillation (VF) Ventricular tachycardia (VT) VT/VF Rapid, uncoordinated contractions of the heart muscle. The cloth that holds the electrode belt in place against the patients skin. Implantable cardioverter defibrillator. Is implanted in the chest and is used to treat abnormal heart rhythms. Units of measurement of shock energy. Myocardial infarction or heart attack. The damaging or death of a region of heart muscle usually resulting from a blocked blood supply to that area. Sudden cardiac arrest. Sudden cardiac death. Usually follows SCA. The large electrodes (one pad in front; two pads in back) that deliver defibrillating energy to treat SCA. Rapid, uncoordinated, and ineffective beating of the ventricles (lower portion) of the heart. Can be fatal if untreated. The lower portion of the heart muscle beats at a fast, abnormal rate. This can lead to VF if untreated. Ventricular tachycardia/ventricular fibrillation. Primary abnormal heart rhythms responsible for SCA. 1-800-543-3267 Page B-1 LifeVest 4000 Patient Manual This page intentionally left blank. Page B-2 1-800-543-3267 Appendix C: Symbols Symbols Cell modem selected: Cellular modem is selected. LifeVest is in range of the cell network and can transmit data. Number of bars indicates signal strength. No cell signal: No data can be sent via cell network. Cell modem is not functioning. Bluetooth signal strength: Indicates signal strength from charger. Number of pie pieces indicates signal strength. Signal must be present in order to send data from monitor to charger. No Bluetooth signal: No data can be sent between monitor and charger. Battery level (on monitor): Number of bars indicates battery charge. Battery charging (on charger): Animated to show that battery is charging. Battery empty (on monitor): Battery is discharged. Battery will still operate for a while but should be changed. Battery testing: Animated to show that battery is being tested. Battery problem: Battery has a problem and may need to be replaced. Call ZOLL Lifecor. Battery low: Battery is low, a critical situation. Change battery as soon as possible and recharge battery. Tap for help. Battery may be defective: LifeVest cannot determine battery condition. Call ZOLL Lifecor for service. Tap for help. Menu button: Tap to see menu. OK button: Tap to acknowledge that you have read the screen. If any selections or changes were made on the screen, they take effect. Cancel button: Tap to back out of the screen. If any changes were made, they are disregarded. Translate button: Tap to change the language on the screen to the secondary language. Only shown when there is a secondary language. 1-800-543-3267 Page C-1 LifeVest 4000 Patient Manual Help button: Tap to see help screen. X button: Tap to close the screen. Next page button: Tap to go to the next page when there is more than one. Previous page button: Tap to go to the previous page when there is more than one. Charger problem: Charger has a problem and cannot be used. Call ZOLL Lifecor immediately. ECG sensor good signal: Situation normal, no action required. ECG sensor poor signal: Check sensor for cause of poor signal and fix problem. ECG sensor off skin: Check sensor that is off skin and fix problem. Therapy pad on skin: Situation normal, no action required. Therapy pad off skin: Check electrode that is off skin and fix problem. Land line dialing mode: Shows that LifeVest is connected to a land line phone. Land line dialing mode with sound: Shows that LifeVest is connected to a land line phone and that sound will be heard when phone connection is attempted. Monitor transmitting: Monitor is transmitting data to the charger. Monitor trying to connect: Monitor is trying to connect to the charger. Airplane mode: Monitor will not transmit data. Monitoring mode: Animated to show that LifeVest is in monitoring mode. Situation normal, no action required. Page C-2 1-800-543-3267 Standby mode: Animated to show that LifeVest is in standby, not monitoring. Connect belt to monitor so that LifeVest can resume normal monitoring mode. Symbols Recording: LifeVest is recording your ECG signal (manually activated). Service required: Device has a problem and requires service. Call ZOLL Lifecor. Battery: Do not incinerate. Battery: Do not short circuit. Caution: Read and follow the caution text next to this symbol. If on a product, consult accompanying documents. CE marking, indicates conformance with European Medical Device Directive. Laundering symbol: Normal cycle in warm water. Laundering symbol: Tumble dry warm. Laundering symbol: Only non-chlorine bleach, when needed. Laundering symbol: No anti-static spray. Laundering symbol: Iron on low temperature. Laundering symbol: No fabric softener. Manufacturing date. Expiration date. Monitor connector: Type BF defibrillator-proof connector. 1-800-543-3267 Page C-3 LifeVest 4000 Patient Manual Packaging: Battery Packaging: Charger. Packaging: Monitor. Packaging: Electrode belt. Packaging: Garment. Power supply electrical information: Alternating current (AC). Power supply electrical information: Direct current (DC). Therapy pad label: Place this side (foil side) of the therapy pad next to your skin. Page C-4 1-800-543-3267 Index A abnormal heart rhythm, 5-2 AC power symbol, C-4 add gel, 5-15 add gel or replace belt message, 5-5 address ZOLL Lifecor, ii adjust belt message, 5-5 what to do, 5-10 airplane mode, 3-16 quick reference, A-2 airplane mode symbol, C-2 alarms, 5-1 alert gong, 5-1 siren, 5-1, 5-2 vibration, 5-1 alert response quick reference, A-3 alerts adjust belt, 5-10 check belt, 5-11 ECG noise, 5-10 gong, 5-4 responding to, 5-1 types, 5-1 antenna on charger, 2-4 antenna symbol on charger, 2-6 arrhythmia, 5-2 defined, B-1 assemble electrode belt and garment quick reference, A-1 asystole defined, B-1 device disabled message, 5-18 B backup power, 3-4 base unit, 2-4 bathing, 3-2 batteries, 2-4 battery charge time, 3-4 inserting, 3-7 latch, 3-7 recharge, 3-7 recycling, 3-21 removal, 3-7 1-800-543-3267 ventilation, 3-4 battery care, 3-4 battery charger, 2-4 indicators, 2-4, 3-9 battery charging symbol, C-1 battery defective symbol, C-1 battery empty symbol, C-1 battery label symbols, C-3 battery level, 2-5 message, 3-3 battery level symbol, C-1 battery low symbol, C-1 battery problem symbol, C-1 battery recharge quick reference, A-1 battery symbol, C-1 battery testing symbol, C-1 belt, 2-3 assembly, 4-1 connector, 2-2 disassembly from garment, 4-8 removal, 4-7 belt maintenance, 5-7 belt sensors, 2-3 BF symbol, C-3 blue gel, 5-3 leaking, 3-19 Bluetooth signal strength symbol, C-1 bra wearing, 4-5 buzzer box on belt, 2-3 C call ambulance message, 5-18 call doctor, 5-3 call for service, 5-6 Cancel button, C-1 cardioversion defibrillation defined, B-1 carrier case, 2-1 caution symbol, C-3 cautions, 1-2 and warnings, patient, 1-2 CE symbol, C-3 cell modem selected symbol, C-1 cell phone interference, 1-5 cell signal unknown, C-1 change battery message, 5-6 change garment, 3-2 quick reference, A-2 Index Index-1 LifeVest 4000 Patient Manual changing electrode belt, 5-16 chapters of this manual, 1-1 charge time battery, 3-4 charger, 2-4 indicators, 3-9 touchscreen, 2-6 charger dim, 3-8 charger interference, 1-5 charger jacks, 2-4 charger menu, 2-6 charger power supply, 2-4 charger problem symbol, C-2 charger setup, 3-5 charger status, 2-6 charger touchscreen, 2-4 check belt message, 5-6 what to do, 5-11 check therapy pads message, 5-5, 5-12 what to do, 5-12 clean garment, 3-19 parts, 3-19 clean skin message, 5-17 cleaning garment, 4-9 cleanup closeout device, 3-21 device, 3-21 code message, 5-6 color code electrodes, 4-3 components, 2-1 connect belt symbol, C-3 connect electrode belt message, 5-4 connecting electrode belt to monitor, 4-6 connector connecting, 4-6 disconnecting, 4-6 electrode belt, 2-2, 2-3 connector, power supply, 2-4 contact ZOLL Lifecor, ii contents of this manual, iii controls monitor, 2-2 copyright, ii cracks housing, 3-19 therapy pads, 3-19 D daily routine, 3-1 quick reference, A-1 data transfer, 3-11 quick reference, A-2 DC power symbol, C-4 defibrillation conventional, warning, 1-2 defined, B-1 description, 2-1 device disabled message, 5-18 disassemble A-2 disconnect device, 3-21 disconnecting electrode belt to monitor, 4-6 electrode belt and garment, 4-8 electrode belt and garment, quick reference, display, 2-2 dizzy, 5-2 doctor call, 5-3 dye blue, 3-19 E ECG electrodes, 2-3 recording, 3-10 ECG electrode symbols, 5-10 ECG sensor symbols, C-2 effective date, ii effectivity, ii electrode connector, 2-2 electrode belt, 2-3 assembly, 4-1 changing, 5-16 connecting, 4-6 connector, 2-3 disassembly from garment, 4-8 disconnecting, 4-6 removal, 4-7 replacing, 5-16 electrode belt and garment quick reference, A-1 electrode belt and garment, disassembly quick reference, A-2 electrode gel, 5-15 electrodes color code, 4-3 Index-2 1-800-543-3267 electromagnetic interference, 1-4 defined, B-1 emergency number doctor, 5-3 EMI. See electromagnetic interference end of use quick reference, A-3 excess gel, 5-17 exclamation point symbol, C-3 expiration date symbol, C-3 F family information, 3-20 fibrillation defined, B-1 finished with device quick reference, A-3 front therapy pocket, 4-3 G garment, 2-3 assembled, 4-4 assembly, 4-1 changing, 3-2 cleaning, 4-9 disassembly, 4-8 on patient, 4-5 removal, 4-7 washing, 3-2 gel add, 5-15 caution, 1-3 leaking, 3-19 gel packets, 5-15 gel release, 5-3 gel, too much, 5-17 gelled, 5-3 glossary, B-1 gong alert, 5-1 garment stretching wash to prevent, 5-13 quick reference, A-4 responding, 5-4 green ECG sensor symbol, C-2 green sensor symbol, 5-10, 5-12 green sticker on therapy pads, 4-3 green stickers label symbol, C-4 on therapy pads, 5-14 Index green therapy pad symbol, C-2 H hand lotion on electrodes, 4-5 heart attack, B-1 heart rhythm, 5-2 recording, 3-10 heart sensors, 2-3 heat battery, 3-4 help button, C-2 help screens, 2-7 holster, 2-1 wearing, 3-2 housing cracks, 3-19 I ICD. See implantable cardioverter defibrillator icons, C-1 implantable cardioverter defibrillator defined, B-1 indicators monitor, 2-2 info screens, 3-18 inserting battery, 3-7 inspection, 3-19 interference, electromagnetic, 1-4 interference, wireless, 1-5 introduction, 1-1 J joules defined, B-1 L land line symbol, C-2 latch, battery, 3-7 laundering garment, 4-9 symbols, C-3 logo message, 3-3 lotion on ECG electrodes, 5-11 M manual organization, 1-1 manufacturing date symbol, C-3 menu button, C-1 charger, 2-6 1-800-543-3267 Index-3 LifeVest 4000 Patient Manual monitor, 2-5 message add gel or replace belt, 5-5 adjust belt, 5-5 battery level, 3-3 change battery, 5-6 check belt, 5-6 check therapy pads, 5-5 connect electrode belt, 5-4 no rate, 5-4 patient name, 3-3 performing belt maintenance, 5-7 please wait, 5-7 red battery, 5-4 release response buttons, 5-8 respond, 5-8 startup, 3-1 time to connect modem, 5-8 too much gel, 5-9, 5-17 treatment delivered, 5-7 wrench code, 5-6 yellow battery, 5-4 messages gong alarm, 5-4 quick reference, A-4 metallic mesh pockets, 4-5 MI. See myocardial infarction modem, 2-4 monitor, 2-2 connecting electrode belt, 4-6 disconnecting electrode belt, 4-6 removal, 4-7 touchscreen, 2-5 monitor menu, 2-5 monitor touchscreen, 2-2 monitor transmitting symbol, C-2 monitor trying to connect symbol, C-2 monitoring mode symbol, C-2 myocardial infarction, B-1 N next page button, C-2 no Bluetooth signal symbol, C-1 no cell signal symbol, C-1 noise alerts, 5-10 noisy ECG signal, 5-5 normal startup routine, 3-3 O OK button, C-1 operation, LifeVest, 3-1 organization of this manual, 1-1 P packaging symbols, C-4 patents, ii patient warnings and cautions, 1-2 performing belt maintenance patient name message, 3-3 message, 5-7 phone number, ii phone jacks, 2-4 please wait message, 5-7 position of garment, 4-5 power outage, 3-4 power supply, 2-4 power supply connector, 2-4 power symbols, C-4 prescription note, ii previous page button, C-2 proper fit of garment, 4-5 Q quick charts, A-1 R rear therapy pockets, 4-2 recharge batteries, 3-7 quick reference, A-1 recording heart rhythm, 3-10 recording symbol, C-3 recycling batteries, 3-21 Index-4 1-800-543-3267 red battery message, 5-4 red battery symbol, C-1 red sensor symbol, 5-10, C-2 red therapy pad symbol, 5-12, C-2 release date, ii release response buttons message, 5-8 removal device, 3-21 remove before bathing or showering, 3-2 quick reference, A-1 removing battery, 3-7 device, 4-7 electrode belt, 4-7 electrode belt from garment, 4-8 replacing belt, 5-16 rescue defibrillation, 1-2 respond message, 5-8 to alerts, 5-1 response buttons location, 2-2 when to press, 5-2 return LifeVest device, 3-21 rhythm abnormal, 5-2 S safety information, 1-2 save heart rhythm, 3-10 SCA. See sudden cardiac arrest SCD. See sudden cardiac death sections of this manual, 1-1 send back LifeVest device, 3-21 send data quick reference, A-2 sending data, 3-11 sensor symbols, 5-10, C-2 sensors on belt, 2-3 service code message, 5-6 service symbol, C-3 showering, 3-2 shutdown device, 3-21 signal strength, antenna symbol, 2-6 siren alert, 5-1 responding, 5-2 skin cream on electrodes, 4-5 Index software license, ii speak options, 3-14 quick reference, A-2 standby mode symbol, C-3 startup message, 3-3 routine, 3-3 vibration, 3-3 startup message, 3-1 startup routine quick reference, A-1 stretching garment wash to prevent, 5-13 sudden cardiac arrest, B-1 sudden cardiac death, B-1 symbols, C-1 system description, 2-1 system info screens, 3-18 T tactile stimulator on belt, 2-3 TE (therapy electrodes), 2-3 telephone jacks, 2-4 therapy pad symbols, 5-12, C-2 therapy pads, 2-3 check, 5-12 cracks, 3-19 green stickers, 5-14 label symbol, C-4 therapy pocket front, 4-3 rear, 4-2 time to connect modem message, 5-8 too much gel message, 5-9, 5-17 touch to speak, 2-7 touchscreen charger, 2-5, 2-6 touchscreen, charger, 2-4 touchscreen, monitor, 2-2 trademarks, ii transfer data, 3-11 quick reference, A-2 translate button, 2-7, C-1 transmitting (monitor) symbol, C-2 travel caution, 1-3 treatment, 5-3 quick reference, A-2 treatment delivered message, 5-7 1-800-543-3267 Index-5 LifeVest 4000 Patient Manual two toned alarm, 5-1 U unable to send data, 3-13 unclear ECG signal, 5-5 unconscious, 5-2 underwear wearing, 4-5 using LifeVest, 3-1 V ventricular fibrillation defined, B-1 ventricular tachycardia defined, B-1 VF. See ventricular fibrillation vibration at startup, 3-3 vibration alert, 5-1 vibration box, 2-3 position, 4-2 VT. See ventricular tachycardia W warm battery, 3-4 warnings, 1-2 and cautions, patient, 1-2 wash garment, 3-2 washing garment, 4-9 water temperature wearing garment, 4-5 wearing LifeVest for washing garment, 4-9 quick reference, A-1 Web address company, ii wetness, 5-3 wireless interference, 1-5 wrench code message, 5-6 wrench symbol, C-3 X X button, C-2 Y yellow battery message, 5-4 yellow battery symbol, C-1 yellow sensor symbol, 5-10, C-2 Z ZOLL Lifecor address, ii Index-6 1-800-543-3267