FCC ID: QBI-1006 Monitor

HOME HEART MONITORING Patient Education Guide DRAFTT A B L E O F C O N T E N T S 1. INTRODUCTION ...................................................................................... 1 How the CardioNet Service Works ............................................................ 2 The CardioNet Monitoring Kit ................................................................... 4 Who to Call for Help ................................................................................... 8 2. SETTING UP ............................................................................................ 9 Connecting At Home ............................................................................... 10 Setting Up the Base .................................................................................. 11 Checking Battery Power ........................................................................... 12 Staying in Range ........................................................................................ 12 Limitations of Cell Phone Coverage ....................................................... 12 Wearing the CardioNet Sensor ................................................................ 14 Placement of Lead Wires and Pads ......................................................... 15 3. USING THE MONITOR .......................................................................... 17 Monitor On and Off .................................................................................. 18 Using the Touch Screen ............................................................................ 20 Recording a Symptom .............................................................................. 23 When You Are Without Cell Phone Coverage ....................................... 27 Changing Monitor Options ...................................................................... 28 Checking Monitor Status .......................................................................... 30 Viewing the Cell Signal Status.................................................................. 32 Warnings and Alarms ................................................................................ 33 4. SENSOR CARE ....................................................................................... 35 Changing Electrode Pads......................................................................... 36 Placing the Leads and Pads .................................................................... 39 Showering or Bathing ............................................................................... 40 Changing the Battery ................................................................................ 42 5. TROUBLE SHOOTING ........................................................................... 43 Responding to Warnings and Alarms ..................................................... 44 Cautions ..................................................................................................... 56 6. SPECIFICATIONS, COMPLIANCE AND SYMBOLS ................................ 59 Contents i DRAFT Caution:

Caution:

Caution: Federal law restricts this device Caution:

Caution:

to sale by or on the order of a physician. Copyright 2004 All rights reserved Model Number 1001 Lit Number - 100526 !!!!! Revision B !!!!! February 2004 ii 1 I N T R O D U C T I O N We Help Find Answers The CardioNet Service monitors your heart rhythms continuously. This helps your doctor detect problems that occur infrequently, even while you sleep. CardioNet works with you and your physician. The CardioNet Service was developed to help doctors detect and treat heart problems that may not happen often enough to be found during a routine ECG in the physicians office. CardioNet monitors heart rhythm continuously, while people go about their normal daily activities. We can help physicians detect problems that may occur infrequently, whether you feel them or not, even while you are sleeping. Our goal at CardioNet is to work as a team with patients and physicians to help people receive the best possible care. We are honored that we were chosen to serve you. Introduction 1 n o i t c u d o r t n I

. 1 HOW THE CARDIONET SERVICE WORKS When youre using the CardioNet Service, youll wear a small, lightweight sensor. The sensor monitors each heartbeat and sends data to the portable CardioNet monitor. The CardioNet monitor can be tucked away in a pocket or purse. It sends wireless communications to the CardioNet Center automatically when it detects an event, or when you report an event using the touch screen on the monitor. Lightweight sensor monitors each heartbeat. CardioNet monitor sends your information to the CardioNet Center Sensor with lead Wires 2 Introduction 1

. I n t r o d u c t i o n CardioNet Patient Service Center Monitors Heart Rhythms The CardioNet Patient Service Center operates 24 hours a day, seven days a week. At the Center, specially trained cardiac technicians analyze your heart rhythms and report results to your physician. Your physician reviews the results, discusses results with you and prescribes or adjusts treatment. Physician Reviews Results Introduction 3 THE CARDIONET MONITORING KIT The CardioNet Monitoring Kit contains the supplies you will need while you are on the CardioNet Monitoring Service. If any items are missing or broken, or if you have any questions about how to use them, please call the CardioNet Patient Service Center at 1-866-426-4401. When service is ended, please return all the items to their labeled slots and send the kit back to the monitoring center, following the directions on the enclosed return address label. It is important to return the patient supply kit no later than the very next day. Other patients may need to use the equipment. YOUR SERVICE KIT CONTAINS 1.1.1.1.1. The CardioNet Monitor The CardioNet Monitor The CardioNet Monitor The CardioNet Monitor The CardioNet Monitor This portable device constantly monitors your heartbeat and sends information to the CardioNet Patient Service Center. The CardioNet monitor uses wireless communication when you are away from home. It uses the regular phone system when the monitor is placed in the CardioNet base station. You will not be charged by the telephone company for calls made by your monitor. Please handle the CardioNet monitor with care dont drop it, lose it, or get it wet. n o i t c u d o r t n I

. 1 Avoid extra charges. Return all kit items except used batteries and used electrode pads to CardioNet when service is completed. You might receive the latest version of the CardioNet Monitor, which has a color screen. 1. CardioNet Monitor 4 Introduction 1

. I n t r o d u c t i o n 2. CardioNet Base Station 2.2.2.2.2. The CardioNet Base Station The CardioNet Base Station The CardioNet Base Station The CardioNet Base Station The CardioNet Base Station The CardioNet base station is connected to your home telephone line and plugged into an electrical outlet in the bedroom or a central location in your house. The base station recharges the CardioNet monitor overnight and allows the CardioNet monitor to communicate with the monitoring center through the regular phone system. You will not be charged by the telephone company for calls made by your monitor. Please put the CardioNet monitor in the base station whenever you are at home. In larger homes, two base stations may be required, so you can keep your sensor and monitor in contact as you walk around the house. Introduction 5 n o i t c u d o r t n I

. 1 3. CardioNet Sensor 6 Introduction dioNet Sensor and Lead Wiririririreseseseses dioNet Sensor and Lead W dioNet Sensor and Lead W The Car The Car 3.3.3.3.3. The Car The CardioNet Sensor and Lead W dioNet Sensor and Lead W The Car The CardioNet sensor, which can be worn around the neck or on a belt, senses each heartbeat and constantly sends the information to the CardioNet monitor. To communicate with the monitor, the sensor must remain within 30 feet of the monitor. Walls and other obstructions can reduce the range. If you go out of communication range, the sensor will beep to alert you to either move back within range or to pick up the monitor and take it with you. 4.4.4.4.4. Electrode Pads Electrode Pads Electrode Pads Electrode Pads Electrode Pads These sticky disposable pads snap onto the three electrode leads on the CardioNet sensor. You remove the backing and stick them onto your skin. 5.5.5.5.5. Batteries Batteries Batteries Batteries Batteries These batteries are for the CardioNet sensor. The sensor battery must be replaced each day. Any new commercially available AA battery can be used with the CardioNet sensor. 6.6.6.6.6. Sensor Neck Strap Sensor Neck Strap Sensor Neck Strap Sensor Neck Strap Sensor Neck Strap Use if you prefer to wear the sensor around your neck. 7.7.7.7.7. Sensor Belt Clip Sensor Belt Clip Sensor Belt Clip Sensor Belt Clip Sensor Belt Clip Use if you prefer to wear the sensor on your belt. 8.8.8.8.8. TTTTTelephone Line In/Out elephone Line In/Out elephone Line In/Out elephone Line In/Out elephone Line In/Out Use to plug your CardioNet base station into the telephone wall jack. 9.9.9.9.9. Base Power Plug Base Power Plug Base Power Plug Base Power Plug Base Power Plug Use to plug your CardioNet base station into an electrical outlet. 10.10.10.10.10.Patient Education Guide & Pocket Reference Card Patient Education Guide & Pocket Reference Card Patient Education Guide & Pocket Reference Card Patient Education Guide & Pocket Reference Card Patient Education Guide & Pocket Reference Card These guides contain helpful information about the CardioNet service and important contact numbers. 11.11.11.11.11.Patient Infor Patient Infor Patient Infor mation V mation V ideo ideo mation Video Patient Information V ideo Patient Infor mation V ideo This ten-minute video contains helpful information about the CardioNet Monitoring Service. 12.12.12.12.12.Retur Retur Retur n Addr n Addr ess Label and Shipping For ess Label and Shipping For ess Label and Shipping Formmmmm Return Addr n Address Label and Shipping For Retur ess Label and Shipping For n Addr Use the label and prepaid shipping form to return the kit after monitoring is finished. Remember: Avoid additional charges. All kit items, except used batteries and used electrode pads must be immediately returned to CardioNet once service is completed, or you will be charged for them. 1

. I n t r o d u c t i o n PATIENT RIGHTS 1. You have the right to be treated with dignity, courtesy and respect 2. You have the right to high quality service 3. You have the right to excellent training on how to use the CardioNet technology and service 4. You have the right to receive high quality service regardless of race, religion, political belief, sex, sexual preference or source of payment 5. You have the right to complain or suggest improvements in service without worrying that we will stop providing service or provide poorer quality of service 6. You have the right to refuse service 7. By federal law (the HIPAA act) you have the right to privacy with regard to your medical information and to control the use of that information The HIPAA act also provides that you have the right to request copies of your medical records and to have corrections made if there are errors in your records PATIENT RESPONSIBILITIES 1. Use the CardioNet equipment with care 2. Return equipment to CardioNet immediately, when monitoring is completed 3. Provide CardioNet with the information we need to provide you with quality care 4. Treat CardioNet employees with respect Introduction 7 n o i t c u d o r t n I

. 1 WHO TO CALL FOR HELP If you have any questions about your monitoring service or billing, please call one of our toll free numbers. Customer service is available 24 hours a day, 7 days a week. MONITORING QUESTIONS: (866) 426-4401 BILLING QUESTIONS: (866) 426-4402 IMPORTANT INFORMATION CardioNet home monitoring is a service used to help doctors diagnose and treat rhythm problems, not an emergency response service. If you require immediate medical assistance, you should contact Emergency Medical Services (9-1-1 in most communities). It is possible that CardioNet could detect a problem that needs immediate attention while a patient is being monitored. If we do detect a problem that needs immediate attention, we will attempt to notify you so that you can obtain assistance from Emergency Medical Services. Our ability to contact and assist patients is limited by several factors such as cell phone coverage, our ability to determine patient location and differing Emergency Medical Services policies and systems in local communities. 8 Introduction 2 S E T T I N G U P This section describes:

" Connecting the CardioNet Base

" Recharging the Battery

" Staying in Communications Range

" Wearing the Sensor Setting Up 9 p U t e S

. 2 CONNECTING AT HOME To connect the CardioNet base, find an electrical outlet and phone jack in a central location, preferably in your bedroom. As long as you are within range of the CardioNet monitor, your CardioNet sensor can continue sending heartbeats to the monitor. If you go out of range, the sensor beeps to alert you. When you go to any area in your house where your sensor is out of communications range with your monitor, simply take the CardioNet monitor out of the recharging base and bring it with you. In larger houses, a second base station is often used so that you can stay within range without carrying your monitor around. At night, keep the CardioNet monitor in the recharging base near your bed. If you sleep on your stomach, your body may block communications between the monitor and the sensor and you may need to put the sensor next to your pillow. Whenever possible keep the monitor in the base. It takes around four hours in the base station to completely recharge the monitor battery. 10 Setting Up 2

. S e t U p PHONE IN PHONE OUT PC POWER Phone In

(your phone line) Line Out

(phone line from Service Kit) Power

(Insert power line) SETTING UP THE BASE 11111. Find an electrical outlet located close to a phone jack, preferably in your bedroom. 22222. Unplug the telephone line from the back of your telephone. 3. Take the telephone line that you just unplugged and plug that line into the slot on the base labeled Phone In. 4. Locate the second telephone line included in your CardioNet Service Kit. Plug one end of this line into the slot on the base labeled Line Out. Plug the other end of this line into the back of your telephone. 5. Locate the power cord in your CardioNet Service Kit. Insert the small, round end of this line into the slot on the base labeled Power. Plug the other end into an outlet. Setting Up 11 p U t e S

. 2 CHECKING BATTERY POWER See Page 20 for more details about checking battery power. When your monitor is in the base, touch the battery symbol on the screen and the unit will tell you if the battery is fully charged. If the battery is not fully charged, leave the monitor in the base for a full recharge, which takes four hours. At home, leave the monitor in the base whenever possible. STAYING IN RANGE The monitors rechargeable battery provides between 12 and 16 hours of use for each four hours of recharging. If your battery indicator is low and it is still early in the day, we recommend you place the monitor in the base for recharging. When you are at home, leave the monitor in the base, unless you go to a part of the house where the sensor and monitor would be out of communications range. Whenever you begin to go out of communications range, the sensor will beep to alert you reminding you either return within range or take your monitor with you. LIMITATIONS OF CELL PHONE COVERAGE When your CardioNet monitor is in the base station, it uses the regular telephone system for communications with the CardioNet center. When you are away from home or whenever your CardioNet monitor is out of the base station the monitor uses cell phone technology to contact the CardioNet center and transmit ECG data. As with consumer cell phones, calls can sometimes be delayed or blocked by coverage problems, heavy traffic on cell phone networks, or physical obstructions such as buildings or mountains. 12 Setting Up 2

. S e t U p When the CardioNet monitor has data to transmit and is unable to communicate with the CardioNet center through cell phone communications, it will save the data and transmit it to the Center through the phone line when it is replaced in the base. Place Monitor in Base to Recharge Setting Up 13 p U t e S

. 2 WEARING THE CARDIONET SENSOR The CardioNet sensor uses three electrode pads, carefully placed on your body to detect heartbeats by sensing electrical changes on the surface of your skin. The electrode pads are attached to the sensor by three lead wires: a white wire, a black wire and a red wire. The lead wires can be snapped on and off the electrodes. This allows you to take off the lead wires and attached sensor before showering without removing the electrodes. See Page 36 for more details about removing your sensor while showering. If you notice an irritation or a rash developing where you place the electrode pads, please call us. You may need to use a different type of electrode pad. Sensor with Lead Wires 14 Setting Up 2

. S e t U p Placement of Lead Wires and Pads The electrode pads are placed as shown in the diagram below. White lead snaps on an electrode pad placed just below the center of your right collarbone. Black lead snaps on an electrode pad placed just below Red lead the center of your left collarbone. snaps on an electrode pad placed just on your left side, on the lower part of your rib cage. Upper Right Chest Upper Left Chest Lower Left Rib Cage Upper Right Chest White Lead Upper Left Chest Black Lead Lower Left Rib Cage Red Lead When you enroll in the CardioNet System, you will be shown the best locations for the electrode pads to detect changes in heart rhythms. Upper Right Chest White Lead Upper Left Chest Black Lead Lower Left Rib Cage Red Lead Placement of Pads Placement of Leads Shown with Neck Strap Placement of Leads Shown with Belt Buckle Setting Up 15 p U t e S

. 2 SKIN PREP This is a protective barrier for patients with known sensitivity or adhesion difficulties. Apply to clean, dry skin before electrode placement and allow to dry completely. Use one skin prep pad for all 3 electrodes. Alternate Placement Areas Alternate Placement for Pads If redness or irritation develops, you can place the electrode pad at another location near the original site. If redness or irritation develops at the alternate site, please call the CardioNet center immediately. 16 Setting Up 3 U S I N G T H E M O N I T O R This section describes:

" Monitor On and OFF

" Using the Touch Screen

" Recording a Symptom

" Cell Phone Coverage

" Changing Monitor Options

" Checking Monitor Status

" Warnings and Alarms The CardioNet monitor is your link with the CardioNet Patient Service Center. The CardioNet sensor sends each heartbeat to the monitor. When the monitor detects a targeted change in rhythm, or when you detect a symptom and enter your information, the monitor will establish a communications link with the CardioNet Patient Service Center. The monitor sends your ECG data, as well as any symptoms and activity information you have entered using the monitors touch screen. Using Your CardioNet Monitor 17 MONITOR ON AND OFF Keep the monitor on at all times while you are on the CardioNet Service, unless you are changing the sensor batteries or not wearing the sensor for example, when you take a shower. See pages 38 - 41 for more information about how to remove the sensor while bathing or showering. r o t i n o M

. 3 When the monitor is awake you see the main menu. When off or asleep, the screen is blank. Touch the button to wake it up. The green button at the bottom of the monitor turns it on or off and wakes it up. To turn the monitor off, you must also use the touch screen to confirm that you want to turn the monitor off. LED Light The CardioNet monitor uses cellular communi-

cations to transmit data when you are away from home. If you have an implanted pacemaker or defibrillator, please follow the manufacturers instructions regarding the use of cell phones.

(See page 55 for more information.) 18 Using Your CardioNet Monitor Touch Screen On/Off Button MONITOR IS ON The LED indicator light flashes green when you are being actively monitored. When the light flashes red, the monitor is trying to get your attention. An alert screen will appear with help or information. MONITOR SCREEN IS ASLEEP To save on battery power, the monitor screen becomes blank while you are not using the touch screen menus. You can tell that the monitor is still on because the LED indicator light will be flashing. To wake the monitor up press the On/Off button. The screen information will appear. MONITOR IS OFF When you turn the monitor off, the screen is blank and the LED indicator light is not lit. 3

. M o n i t o r The LED light still flashes when the monitor is asleep. It goes off when the monitor is turned off. The screen is blank when the monitor is asleep or turned off. Using Your CardioNet Monitor 19 USING THE TOUCH SCREEN The CardioNet monitor has a simple touch screen that is easy to view and use. To make selections, lightly touch the screen with your finger. Each screen that appears will guide you through the next step, using menus choices you select. Most screen menus follow a simple pattern. At the top of each there is a prompt line that tells you the next step to take. The midsection lists options that you can choose. At the bottom of most menus are navigation buttons that allow you to move from screen to screen. The two symbols at the bottom of the main menu let you check battery power and the strength of the cell signal. r o t i n o M

. 3 MAIN MENU Press Any Button Prompt Line Record Event View Options Selection Options Check Battery and Cell Phone Coverage Black = Full or Strong White = Getting Weaker 20 Using Your CardioNet Monitor SYMPTOMS MENU Select Symptoms Skipped Beat Light Headed Fainted/Fell Short of Breath Prompt Line Selection Options Back Next Navigation Buttons 3

. M o n i t o r NAVIGATION BUTTONS The navigation buttons at the bottom of each menu move you from screen to screen. Heres what the buttons do:

Confirm OK Back Next Confirm accepts your selection and moves to the next menu. OK acknowledges you have read the information on the screen and closes the current menu. Back moves backward to the previous menu. Next moves forward to the next menu. Silence Silence turns off the audio alarm. Help Help moves to a helpful information screen. Using Your CardioNet Monitor 21 HELP MENU The help and alert screens are slightly different in that the middle section provides additional information. Press Back To recharge Monitor battery:

A) Place Monitor in Base OR B) Insert the charger cord into the bottom of your Monitor. Prompt Line Helpful Information Back Navigation Button to Close Screen r o t i n o M

. 3 22 Using Your CardioNet Monitor RECORDING AN EVENT Your symptom and activity data is very important information that helps your physician treat or manage your condition. By entering your symptoms and activities each time you have an event, you will assist your physician in determining the best treatment. To Record a Symptom 1. Make sure the monitor is on. If the screen is blank, press the On/Off button to turn on the monitor. The Main menu appears. Press Any Button Record Event View Options 2. On the Main menu touch Record Event. To turn your monitor screen on, either touch the blank screen or press the On/Off button. 3

. M o n i t o r Using Your CardioNet Monitor 23 A confirmation screen appears asking if you want to report an event. Remember that there are two Symptoms menus. Press Yes or No Do you want to report an event?

Yes No r o t i n o M

. 3 3. Touch Yes. If you have touched the Record Event screen by accident and do not wish to report an event, touch NO and you will return to the Main Menu. first first two two first of two The first two Symptoms menus appears. two first Select Symptoms Skipped Beat Light Headed Fainted/Fell Short of Breath Back Next 24 Using Your CardioNet Monitor Select, one by one, each and every symptom that you feel. A check mark will appear next to symptoms you select. Touch Next. second second second Symptoms menu appears. The second second Select Symptoms Chest Discomfort Fatigue Heart Racing None of the above Back Confirm Select any or all symptoms or touch None of the above. When done, touch Confirm to move to the Activities menu. The Activities menu appears. Select Activity Resting Light Activity Moderate Activity Heavy Activity Back Confirm Using Your CardioNet Monitor 25 3

. M o n i t o r 4. Choose the activity that best reflects your level of exertion when you felt the symptom. When done, touch Confirm. The following screen appears. Press OK for Main Menu Selections recorded. Attempting to connect to the CardioNet Center. OK 5. Touch OK. The monitor then attempts to send your activity information and your ECG data to the CardioNet Patient Service Center. r o t i n o M

. 3 26 Using Your CardioNet Monitor WHEN YOU ARE WITHOUT CELL PHONE COVERAGE When the CardioNet monitor is not in its base station, it uses wireless telecommunications to communicate with the CardioNet Patient Service Center. If you are in an area without cell phone coverage and the monitor is unable to establish a connection with the Patient Service Center, the monitor stores the information it has collected and sends it later. Press Help or OK Cell phone unable to connect. Your Monitior will continue to redial. Press Help for options. Help OK Monitor Cannot Establish Connection 3

. M o n i t o r Using Your CardioNet Monitor 27 CHANGING MONITOR OPTIONS Your CardioNet monitor lets you make adjustments to suit your needs. Adjustable features include:

! Volume

! Contrast

! Cellular Power (on or off)

! Manual Transmission Adjust Features 1. Make sure the monitor is on. The Main menu appears. r o t i n o M

. 3 Press Any Button Record Event View Options 28 Using Your CardioNet Monitor 2. Touch View Options. The Options menu appears. Select Option Volume Contrast Cell Phone Manual Transmission Back More ... 3. Choose any of the following options. Volume adjusts the alarm tone to high, medium, low or vibrate. After making your selection, youll hear the volume you have chosen. For Vibrate, you can feel the monitor vibrating. Contrast adjusts the screen contrast to high, medium or low. After you make your selection the screen will adjust to the new brightness setting. You might find you need a different setting when you are outdoors rather than indoors. Cell Phone turns the cell phone in the monitor OFF or ON. When the cell phone is off, the monitor is still recording heartbeats, but no data can be sent to the CardioNet Patient Service Center until the monitor is placed in the base. Manual Transmission is currently not available. Back returns to the Main menu. More ... allows authorized technicians to check the monitor setup and modify landline dial parameters. See page 30 for more information. 4. After you make your selections, a screen will appear to ask you to confirm the selected option. Touch Confirm. Using Your CardioNet Monitor 29 3

. M o n i t o r VERIFYING MONITOR SETUP 1. From the Options menu, touch More ... The Password menu appears. Enter Password

* * * *

1 4 7

*

2 5 8 0 3 6 9

#

Clear Enter 2. Enter the password. The options to verify the monitor setup appear. The following landline dial conditions can be modified. Pulse dialing vs. Tone dialing Dial prefix (For example, 9 to dial out, or *70 to disable call waiting.) r o t i n o M

. 3 30 Using Your CardioNet Monitor CHECKING MONITOR STATUS By touching either the battery or the cell signal icon on the Main menu, you can easily view more information about both. View the Battery Status 1. From the Main menu, touch the Battery icon. Press Any Button Record Event View Options 2. The Battery Information menu appears. Press OK Battery time remaining Sensor: 80%

Monitor: 75%

OK 3

. M o n i t o r Choose the Battery icon to check the power level of the monitor battery. The monitors rechargeable battery provides between 12 and 16 hours of use for every four hours of recharging. See Setting Up

(Page 12) for more information. 3. The screen tells you about sensor and monitor power levels. Touch OK to return to the Main menu. Using Your CardioNet Monitor 31 VIEWING THE CELL SIGNAL STATUS 1. From the Main menu, touch the Cell Signal icon. The Signal Information menu appears. Press OK Cellular signal strength:

Strong OK 2. This menu tells you how strong the cellular signal is in your current location. When done, touch OK to return to the Main menu. Choose the Cell Signal icon to check the strength of the cellular signal in your current location. r o t i n o M

. 3 32 Using Your CardioNet Monitor WARNINGS AND ALARMS The monitor will beep to alert you when it is not able to function properly. The screen display will explain exactly how to respond. Warnings are brief beeps. Alarms last longer and grow louder. Warnings can sometimes resolve themselves, but alarms always require action on your part. With alarms, you can immediately silence the audio tones by touching the Silence button on the touch screen. For both warnings and alarms you can also touch the Help button for more information on resolving the problem. Below are examples of warnings and alarms. See Trouble Shooting

(Pages 44 - 58), for more information about warnings and alarms. 3

. M o n i t o r Press Help or OK Your Monitor battery power is low. Recharge battery soon to ensure continuous monitoring!

Press Help for instructions. Help OK Low Monitor Battery Warning Using Your CardioNet Monitor 33 WARNINGS AND ALARMS CONTINUED Press Help or OK Cell phone unable to connect. Your Monitior will continue to redial. Press Help for options. Press Help or OK Sensor lead wire disconnected. Press Help for instructions. Help OK Help OK Cannot Establish Phone Connection Warning Sensor Lead Wire Disconnected Warning r o t i n o M

. 3 Press Help or OK Your Monitor can not detect a dial tone. Press Help for instructions. Help OK No Dial Tone Warning 34 Using Your CardioNet Monitor 4 S E N S O R C A R E This section describes:

" Connecting the CardioNet Base

" Recharging the Battery

" Staying in Communications Range

" Wearing the Sensor The CardioNet sensor is comfortable, easy to wear, and only requires a small amount of care. We recommend that you change the electrode pads every two days. When you shower or bathe you dont have to remove the electrode pads, but you must remove the sensor and electrode leads. Taking Care of the CardioNet Sensor 35 CHANGING ELECTRODE PADS We recommend that you change your electrode pads every two days. Changing the electrode pads more frequently may cause irritation to the skin. Changing electrode pads less frequently may cause the electrode pads to wear down and weaken the heartbeat signal to the sensor. Any time you change your electrode pads you should turn your monitor off first, using the On/Off button and the confirmation on the touch screen. This prevents the monitor from signaling an alarm because it cannot detect your heartbeats. Next, remove the sensor and old electrode pads. Then, apply new pads. When you enrolled in the CardioNet System, you were shown the locations for the electrode pads that would provide the best possible measurements of changes in heart rhythms. When you replace electrode pads, it is important to put the new electrode pads in the right spots. It is also very important to connect the right color lead to the right electrode so the CardioNet monitoring center receives accurate heartbeat information. r o s n e S

. 4 36 Taking Care of the CardioNet Sensor Turn off the Monitor 1. If the screen is blank, touch it to wake up the monitor. 2. Press the On/Off button located on the front of the monitor. A warning appears and asks if you really want to power down. Press Yes or No Warning:

Monitoring will stop!

Are you sure you want to turn the Monitor off?

Yes No 3. Touch Yes to confirm. A message briefly appears to let you know that the monitor is powering down. Wait for the monitor to completely power down. The touch screen will become blank. 4

. S e n s o r Taking Care of the CardioNet Sensor 37 Tip: If you need to change your electrode pads, its best to do so after showering or bathing. Remove Sensor and Pads 1. Unsnap the sensor leads from the electrodes. 2. Remove the electrode pads from your skin. Throw them away. Apply the New Pad 1. Snap a new electrode pad onto the lead. 2. Peel off the paper in the back of the electrode pad. 3. Check the new electrode pad to make sure the gel on the back has not dried out. Electrodes with dried gel should be thrown away. 4. Apply pad to the same spot. If the skin is irritated, move the electrode to another location near the original site. Place the new pads in the locations you were shown when you enrolled in the CardioNet System. If redness or irritation develops, you can choose another location near the original site. (See page 16.) Upper Right Chest r o s n e S

. 4 Upper Left Chest Lower Left Rib Cage 38 Taking Care of the CardioNet Sensor Placement for Pads PLACING THE LEADS AND PADS Remember that it is important to place the new electrode pads in the right spots, as close as possible to the original pad locations. It is also very important to connect the right color lead to each electrode so the CardioNet Patient Service Center receives accurate heartbeat information. White lead snaps on an electrode pad placed just below the center of your right collarbone. Black lead snaps on an electrode pad placed just below Red lead the center of your left collarbone. snaps on an electrode pad placed just on your left side, on the lower part of your rib cage. Electrode Pad The sensor leads easily snap on and off the electrode pads. Upper Right Chest White Lead Upper Left Chest Black Lead Lower Left Rib Cage Red Lead 4

. S e n s o r Placement for Leads Taking Care of the CardioNet Sensor 39 When youre wearing the sensor on a belt clip, the sensor is upside down. SHOWERING OR BATHING Youll need to remove your sensor and electrode leads before taking a bath or shower, but you can keep the electrode pads on. Before removing the sensor, turn off the monitor. Remove the sensor and leads, but leave the pads in place. To keep them from falling off, try to avoid getting the electrode pads soaked with water. Gently wash the skin around the electrodes. After drying, press the pads to the skin. Turn Off the Monitor 1. Press the On/Off button located on the front of the monitor. A warning appears and asks if you really want to power down. 2. Touch Yes to confirm. A message briefly appears to let you know that the monitor is powering down. Wait for the monitor to completely power down. The touch screen will become blank. You can wear your electrode pads while showering or bathing. But be sure you remove the sensor and electrode leads. After showering, press the pads to the skin to assure tight surface contact. r o s n e S

. 4 40 Taking Care of the CardioNet Sensor Remove the Sensor 1. Remove the sensor leads from the electrodes. 2. Leave the sensor electrode pads in place if you are not going to change them. 3. If you are going to change the pads, remove them and apply a new set after your shower or bath. After showering 1. Press electrode pads worn during showering to the skin or apply new pads. 2. Reattach the sensor lead wires to the correct electrode pads. 3. Press the On/Off button to turn the monitor on and resume monitoring. 4

. S e n s o r Taking Care of the CardioNet Sensor 41 Call the CardioNet Patient Service Centers toll free number if you are getting low on replacement batteries. Call:

(866) 426-4401 CHANGING THE BATTERY The AA battery in the sensor must be replaced with a new, unused battery every 24 hours. We recommend you turn your monitor off before changing your sensor battery. This prevents the monitor from signaling an alarm because it cannot detect your heartbeats. Replace the Battery 1. Pull open the battery door. 2. Remove the old battery and dispose of it in accordance with local regulations and EPA guidelines. 3. Put in a new AA battery, included in your CardioNet Service Kit. Insert the positive end as shown. The sensor chimes when the battery is correctly placed. 4. Close the cover. If you are getting low on replacement batteries, contact the CardioNet Patient Service Center and ask for additional batteries. In an emergency, any available AA battery can be used with the CardioNet sensor. r o s n e S

. 4 Pull the top edge of the battery door to open it. Insert the positive end as shown. The sensor chimes when the battery clicks in correctly. If theres no chime, you probably have the battery backwards. 42 Taking Care of the CardioNet Sensor 5 T R O U B L E S H O O T I N G This section describes:

" Responding to Warnings and Alarms

" Trouble Shooting

" Precautions and Cautions

" Cleaning

" Service Trouble Shooting 43 RESPONDING TO WARNINGS AND ALARMS The monitor will beep to alert you when it is unable to function properly. The touch screen will explain what to do. Warnings are brief beeps. Alarms last longer and grow louder. Warnings can sometimes fix themselves, but alarms always require action on your part. For alarms, you can immediately silence the audio tones by touching the Silence button on the touch screen. With both warnings and alarms you can also touch the Help button for more information. The following examples of alarms and warnings show what appears on your screen and advise you on how to solve the problem. LOW MONITOR BATTERY WARNING Problem: Monitor battery is low. Solution: Return the monitor to the base for recharging. Press Help or OK Your Monitor battery power is low. Recharge battery soon to ensure continuous monitoring!

Press Help for instructions. Help OK t o o h s e b u o r T l

. 5 44 Trouble Shooting LOW SENSOR BATTERY WARNING Problem: Sensor battery is low. Solution: Install new battery. Or, if the battery is new, inspect battery compartment and clean contacts if necessary. Press Help or OK Your Sensor battery power is low. Replace battery soon to ensure continuous monitoring!

Press Help for instructions. Help OK NO POWER IN BASE WARNING Problem: Power cord is disconnected. Solution: Reinsert the power cable into the base and into the wall outlet. Press Help or OK No power to Base Press Help for instructions. Help OK Trouble Shooting 45

. 5 T r o u b e s h o o t l If the electrode pad loses contact or dries out you need to replace it immediately. The monitor detects when leads are disconnected and will alert you. SENSOR LEAD WIRE DISCONNECTED WARNING Problem: Either leads or pads are loose. Solution: Make sure the electrode pads are pressed onto your skin. Check all the lead wire attachments. Press Help or OK Sensor lead wire disconnected. Press Help for instructions. Help OK t o o h s e b u o r T l

. 5 46 Trouble Shooting POOR SENSOR COMMUNICATION WARNING Problem: Sensor and monitor are having trouble communicating. Solution: Move closer to your monitor or move the monitor closer to you. The monitor and sensor need to be in closer range to communicate. Press Help or OK Poor communications between your Monitor and your Sensor. Press Help for more information. Help OK Trouble Shooting 47

. 5 T r o u b e s h o o t l SCHEDULED UPLOAD FAILED WARNING Problem: Monitor needs to transmit data but cant establish a connection. Solution: Put the monitor in the base. Press Help or OK Your Monitor is trying to send data automatically and can not establish a phone connection. Press Help for options. Help OK t o o h s e b u o r T l

. 5 48 Trouble Shooting POOR SENSOR COMMUNICATION ALARM Problem: Sensor and monitor are not communicating. Solution: Check for causes. Is there too much distance between them? Are there battery problems with either the sensor or monitor?

Press Help or Silence No communications between your Monitor and Sensor. Press Help for more information. Help Silence Trouble Shooting 49

. 5 T r o u b e s h o o t l EVENT TRANSMISSION ALARM Problem: Monitor has stored ECG data to transmit, but cant establish a connection. Solution: Move to an area that has cellular coverage or put the monitor in the base. If you still are unable to establish a connection, call the CardioNet Patient Service Center for instructions. Telephone (866) 426-4401. Press Help or Silence Your Monitor has detected an event and can not establish a phone connection. Press Help for options. Help Silence t o o h s e b u o r T l

. 5 50 Trouble Shooting EMPTY MONITOR BATTERY ALARM Problem: Monitor is out of power. Solution: Place the monitor in the base. Press Help or Silence Your Monitor battery is empty. Recharge your Monitor immediately. Press Help for instructions. Help Silence EMPTY SENSOR BATTERY ALARM Problem: Sensor battery is out of power. Solution: Install a new AA battery. Press Help or Silence Your Sensor battery is empty. Replace Sensor battery immediately. Press Help for instructions. Help Silence Trouble Shooting 51

. 5 T r o u b e s h o o t l INTERNAL MONITOR ALARM Problem: Monitor is not functioning. Solution: Call the CardioNet Patient Service Center for help. Telephone (866) 426-4401. Press Help or Silence Internal Monitor Error Call CardioNet at 1-866-426-4401 for technical assistance. Press Help for more information. Help Silence t o o h s e b u o r T l

. 5 52 Trouble Shooting TROUBLE SHOOTING Trouble shooting sometimes involves a bit of detective work, but usually the monitor detects problems for you. The monitor beeps to let you know there is a problem and explains on the touch screen exactly how to respond on the touch screen. A warning prompts you to resolve a problem by display-

ing an alert screen and beeping an audio tone. With some warnings the problem can fix itself and you wont need to take any action. With other warnings you will need to take some action, which will be described on the touch screen. An alarm lets you know that a problem has not been fixed and you must take action. MONITOR BATTERY PROBLEMS Ensure battery is being recharged for at least four hours per day. If you find the monitor is not holding its charge long enough, you may not have left it in the base long enough to fully recharge. The monitor must be left in its base for four hours to fully recharge. NO DISPLAY ON MONITOR First, ensure the monitor is turned on. If it is on, the LED will be flashing and the monitor may be low on power. Return monitor to base for recharging. BEEPS IN BED If you wear the sensor around your neck and sleep on your stomach, or if you wear it at your waist and sleep with your sensor side down, you may block communications between the sensor and the base station. This will cause warning beeps. To avoid beeps and maintain the vital communications link, try placing the sensor next to your pillow if you usually sleep on your stomach. If you normally sleep on your side and wear the sensor with a belt clip, make sure you place the sensor on your up side. Trouble Shooting 53

. 5 T r o u b e s h o o t l PHONE BUSY?

When the monitor is in the base station and has information to send to the CardioNet Patient Service Center, it will use your telephone line to transmit ECG data. You will not be charged by the telephone company for these calls. If someone calls you while the monitor is using the line, they will get a busy signal. If you try to place a call while the monitor is transmitting data, you will hear a high-

pitched sound. This is the sound of ECG data being transmitted. If you are expecting a critically important call, or need to place an urgent call while the monitor is transmitting data, you can temporarily remove the monitor from the base. It will either use wireless communications to transmit data to the CardioNet Center or use your telephone line to transmit the data once it is replaced in its base. Please remember to put the monitor back in the base station after you receive or place the telephone call. You should not interrupt an ECG transmission for routine calls. The data that your monitor is sending might need immediate review and response. SKIN IRRITATION If you notice that the skin under or around your electrode pads is becoming sensitive, irritated or painful, or if you develop a rash, please call the CardioNet Patient Service Center. Some people are especially sensitive to different gels and adhesives. You may need to use another type of electrode pad. SENSOR BELT CLIP DIFFICULT TO PUT ON If youre wearing a thicker belt and finding that it is difficult to slide on the Sensor Belt Clip, first remove the CardioNet Sensor from the clip. Slide just the clip onto your belt and then reposition the sensor on the clip. t o o h s e b u o r T l

. 5 54 Trouble Shooting PRECAUTIONS DISPOSE OF BATTERIES PROPERLY Observe all local laws for the disposal of alkaline batteries. WHEN NOT IN USE, REMOVE SENSOR BATTERY Do not leave the battery in the sensor when it is not in use. Damage from corrosion could result. AVOID ELECTROMAGNETIC INTERFERENCE For the best recording results, you should avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc. POTENTIAL FOR ELECTROMAGNETIC INTERFERENCE There is a potential for electromagnetic interference to other devices while using the CardioNet Service. THE CARDIONET SYSTEM WITH IMPLANTED PACEMAKERS AND ICDS (DEFIBRILLATORS) If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended you take certain precautions when using a cellular phone. Since the CardioNet monitor contains a cellular phone, you should take the same precautions when carrying and using the monitor. In general, most manufacturers recommend the following:

! Keep a distance of at least six inches (15 cm) between the cellular phone and a pacemaker or defibrillator.

! Hold the cellular phone on the opposite side of the body from the pacemaker or defibrillator.

! Dont carry a cellular phone in a breast pocket or on a belt if that would place the phone within six inches of the pacemaker or defibrillator. Trouble Shooting 55

. 5 T r o u b e s h o o t l CAUTIONS CAUTION: POWER DOWN AND REMOVE SENSOR BEFORE SHOWERING Power down the monitor and remove the sensor before showering. While the CardioNet sensor and monitor are water resistant, they are not waterproof. Refer to the section: Care for the Sensor (Page 35) for complete instruction on removal and reapplication before showering. CAUTION: DO NOT GET THE MONITOR AND SENSOR WET Make sure the monitor and sensor stay dry at all times. WARNING: FOR ADULT USE ONLY The CardioNet Monitoring System is intended for Adult use only. It shall not be used on infants weighing less than 22 lbs. WARNING: USE WITH TELEPHONE SYSTEM Any patient whose life may be put at significant risk by the unavailability of the telephone system should not be monitored by the CardioNet System. WARNING: NOT AN APNEA MONITOR The CardioNet monitor is not to be used as an apnea monitor. WARNING: USE ONLY CARDIONET ELECTRODES While wearing the CardioNet sensor, use only electrodes provided by CardioNet. WARNING: DO NOT TAMPER There are no serviceable parts in the CardioNet System. Removing the cover of any component may alter performance. t o o h s e b u o r T l

. 5 56 Trouble Shooting WARNING: DO NOT TAMPER WITH MONITOR BATTERY The monitor battery can present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 80C (176 F), incinerate, or recharge using any device other than the base. WARNING: USE ONLY CARDIONET WALL ADAPTER Do not use any wall adapter for the base other than the one provided in the CardioNet Service Kit. WARNING: DO NOT CONNECT ANY DEVICE TO THE PC PORT ON THE BACK OF THE BASE The PC port is to be used only by CardioNet personnel. WARNING: DO NOT USE NEAR FLAMMABLE ANESTHETIC The CardioNet System is not to be used in the presence of flammable anesthetic. CLEANING Clean the plastic case of the monitor and the sensor with a soft cloth dampened with soapy water. Wipe the exter-

nal surfaces of the sensor, monitor and base. Do NOT use soapy water on the touch screen. Clean the screen of the monitor with the screen cloth or cleaning tissues provided with the patient monitoring kit. Trouble Shooting 57

. 5 T r o u b e s h o o t l Do not spray or submerge any component with liquid or foam. Each component should be wiped with a soft damp cloth after cleaning to ensure no fluid has pooled on external surfaces. SERVICE If you experience additional problems with any compo-

nents of the CardioNet Monitoring System, review the problems and solutions listed in the trouble shooting section. If additional assistance is required contact cus-

tomer support. Telephone: (866) 426-4401. Before returning the CardioNet Monitoring System, call customer service to make shipping arrangements. t o o h s e b u o r T l

. 5 58 Trouble Shooting 6 S P E C I F I C A T I O N S , C O M P L I A N C E A N D S Y M B O L S This section describes:

" Specifications

" Symbols

" Hardware Requirements

" FCC Compliance Specifications 59 SPECIFICATIONS PHYSICAL SENSOR 2.7 in. x 0.9 in height Weight: 2.2 oz SENSOR NECK STRAP 24 in. MONITOR 5.8 in x 3.0 in x 1.1 in Weight: 12.8 oz LCD 3.0 x 2.3, touch screen, monochrome, backlight BASE 7.8 in x 4.3 in x 6.1 in Weight: 13.3 oz FUNCTIONAL Sample Rate Resolution Dynamic Range Bandwidth Channels Battery Life Leakage current 250 samples per second 12 bits

+ / -5 mV 0.5 to 40 Hz 2 Monitor: (12-16 hours average with cleared memory and fully recharged battery), rechargeable Sensor: (24 hr) AA Alkaline Less than .1 V Electrodes) 60 Specifications TRANSMISSION Sensor to Monitor Monitor to Center 900 MHz ISM band RF transmission, digital error corrected. 30 foot range, retransmission if data is corrupted. CDMA (PCS & cellular) wireless, digital error corrected. Telephone line modem, digital error corrected. Acoustic transmission, 1500 Hz center frequency, 8 bits resolution, 5 mV dynamic range. ECG recording intervals vary by type of event; the minimum is 15 seconds pre-event and 45 seconds post event. Wireless transmission subject to coverage of cellular network. Data received at Monitoring Center within minutes with good wireless coverage and/or modem communications. Urgent reports processed at time of data receipt. Daily reports processed once a day, by 3 PM. OPERATING CONDITIONS Operating temperature Operating humidity Storage temperature Storage humidity Operation altitude Fluid Ingress Rating Note: Please protect the monitor and sensor from water and other fluids. 20 - 45 o C 10% - 95%, noncondensing

-20 - 55 o C, noncondensing 5% - 95%, noncondensing 700-1060 millibars IPX1 CONNECTORS Base Monitor WALL ADAPTER Manufacturer Model number Power in (15V, 1.2A max) Phone in (RJ-11) Phone out (RJ-11) Power in (15V, 1.2A max) Friwo, Inc. (15V, 1.0A) FW7555M/15 Note: Both the Monitor and Sensor are internally powered continuous operation devices. Specifications 61 STANDARDS COMPLIANCE Monitor Sensor Base EN60601-1 AAMI EC-38 FCC parts 2, 15, 22, 24 EN60601-1 AAMI EC-38 FCC part 15 EN60950 AAMI EC-38 FCC part 15, 68 AECG Equipment Class II Note: This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC or the Electromagnetic Compatibility Directive 89/336/EEC (use applicable directive). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

! Reorient or relocate the receiving device.

! Increase the separation between the equipment.

! Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

! Consult the manufacturer or field service technician for help 62 Specifications EQUIPMENT SYMBOLS Consult Manual 2000 Year of Manufacture Type BF Equipment SN Serial Number Specifications 63 HARDWARE REQUIREMENTS IN HOME REQUIREMENTS Touch tone or pulse telephone or good wireless coverage AC powered electrical outlet with 120 VAC FCC ID Sensor Monitor Monitor Base QBI-1007 Monitor QBI-1006 CDMA N7NSB555 CARDT00B42061 64 Specifications FCC AND INDUSTRY CANADA (CS-03) COMPLIANCE This device complies with part 15 and 68 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 interference received including interference that may cause undesired operation. FCC RULES PART 15 The Model 1001 has been tested and complies with the limits for a class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable pro-

tection against harmful interference when the equipment is operated in a residential environment. This equipment gener-

ates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, can cause harmful interference to radio communications. CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY CARDIONET INC. COULD VOID THE USERS AUTHORITY TO OPERATE THE EQUIPMENT. FCC RULES PART 68 FCC Part 68 Registration The Model 1001 complies with FCC Rules, Part 68. On this equipment is a label that contains, among other information, the FCC Part 68 registration number. REN The ringer equivalence number (REN) is used to determine the quality of devices that may be connected to the telephone line. Excessive RENs on the telephone line may result in the devices not ringing in response to an incoming call. In most, but not all areas, the sum of RENs should not exceed five

(5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. Specifications 65 NOTE: RENs are associated with loop-start and ground-start ports. It is not used for E&M and digital ports. The REN assigned to the Model 1001 is 0.01 B. If requested, this infor-

mation must be given to the telephone company. SERVICE In the event of equipment malfunction, all repairs should be performed by CardioNet Inc. or an authorized agent. It is the responsibility of users requiring service to report the need for service to CardioNet Inc. or to one of our authorized agents. Service can be facilitated through our office at:

CardioNet Inc. 510 Market St. San Diego,CA 92101 619-243-7500 The telephone company can ask you to disconnect the equip-

ment from the network until the problem is corrected or until you are sure that the equipment is not malfunctioning. The Model 1001 interface connects to the Public Switched Telephone Network through a FCC registered NCTE which specifies the type of network jack to be used. DISRUPTION OF THE NETWORK If the Model 1001 disrupts the telephone network, the tele-

phone company can discontinue your service temporarily. If possible, the telephone company will notify you in advance. If advance notice is not practical, they will notify you as soon as possible. You are also informed of your right to file a com-

plaint with the FCC. TELEPHONE COMPANY FACILITY CHANGES The telephone company can make changes in its facilities, equipment, operations, or procedures that can affect the operation of your equipment. If they do, you should be noti-

fied in advance so you have an opportunity to maintain uninterrupted telephone service. 66 Specifications FCC RADIO FREQUENCY EXPOSURE INFORMATION In August 1996, the Federal Communications Commission

(FCC) of the United States, with its action in Report and Order FCC 96-326, adopted an updated safety standard for human exposure to radio frequency (RF) electromag-

netic energy emitted by FCC regulated transmitters. Those guidelines are consistent with the safety standard previ-

ously set by both U.S. and international standards bodies. The design of this device complies with the FCC guide-

lines and these international standards. Use only the supplied antenna. Unauthorized antennas, damaged antennas, modifications, or attachments could impair call quality, damage the device, or result in violation of FCC regulations. Please contact CardioNet if damage to the unit is apparent. Specifications 67 BODY-WORN OPERATION This device was tested with the softcase sup-

plied by CardioNet as an accessory to this device and was found to comply with the FCC exposure requirements. When operating this device, a minimum separation distance of 1.5 cm must be maintained between the users body and the monitor, including its antenna, to comply with the FCC exposure limits. To maintain compliance with FCC RF exposure requirement, use only carrying accessories that maintain a 1.5 cm separation distance between the users body and the device, including the antenna. These carrying accessories should not contain metallic components in its assembly. The use of carrying accessories that do not satisfy these requirements may not comply with FCC RF exposure requirements, and should be avoided. This particular device has not been designed for held-

to-ear use and should never be used against the ear. For more information about RF exposure, please visit the FCC website at www.fcc.gov. 68 Specifications CardioNet Ambulatory ECG System and Arrhythmia Detector Manufactured by CardioNet Inc. 510 Market Street San Diego, CA 92101 Copyright 2002 - 2003 All rights reserved.

CONTENTS Contact Information ................................................................................ 2 Introduction ............................................................................................. 3 Product Description ................................................................................. 4 Service Overview ..................................................................................... 6 Patient Enrollment ................................................................................... 8 Electronic Patient Enrollment ................................................................ 10 Indications and Contraindications.......................................................... 11 Reports .................................................................................................. 12 Physician Notification ............................................................................ 14 Billing ..................................................................................................... 15 Cautions and Warnings .......................................................................... 17 Technical Specifications ......................................................................... 19 Sample Forms and Reports ................................................................... 28 DRAFT 1 CONTACT INFORMATION Main Number

(215) 689-7450

(866) 426-4404 Patient Service Center

(866) 727-3397 Physician Notification

(866) 426-4401 Patient Inquiries Enrollment

(866) 426-4403 Fax Billing

(866) 426-4402 Caution: Federal law restricts this device to sale by or on the order of a physician. Copyright 2004 All rights reserved Lit Number - 100327 !!!!! Revision E !!!!! February 2004 2 INTRODUCTION CardioNet: Mobile Cardiac Outpatient Telemetry CardioNet has developed a new, integrated technology and service Mobile Cardiac Outpatient Telemetry which allows heartbeat-by-heartbeat, ECG monitoring, analysis and response, at home or away, 24/7/365. CardioNets Mobile Cardiac Outpatient Telemetry assists physicians in the diagnosis and management of difficult-to-diagnose arrhythmias. Given the infrequent and asymptomatic nature of some arrhythmias, it is often challenging to capture an actual arrhythmia with conventional monitoring technology, such as Holter and cardiac event monitoring. With the CardioNet System, we are able to automatically detect and capture asymptomatic and symptomatic arrhythmias, based on monitoring parameters defined by the prescribing physician. In addition, the patient can utilize the touch screen on the CardioNet monitor to enter their symptoms and activity level at the time of a documented event. The physician then receives a representative ECG strip of the event; a time and date stamp of the actual event, including symptoms and activity, and is therefore able to make a more informed and accurate diagnosis. CardioNet outpatient telemetry offers physicians a powerful new diagnostic and patient management tool for a wide range of monitoring indications. Patient Monitored 24/7/365 Patient Enters Symptoms and Activities Physician Receives CardioNet Report 3 PRODUCT DESCRIPTION CardioNet merges patient monitoring, wireless communications, and the Internet to allow targeted cardiac rhythm related problems to be identified, quantified, and communicated to the prescribing physician in a timely and efficient manner. The CardioNet System is comprised of a sensor, monitor, and base. The lightweight sensor is worn by the patient on a lanyard or belt clip, it continuously records two channels of ECG, and transmits the ECG by a radio frequency (RF) link to the monitor. The sensor is powered by a disposable alkaline battery, which typically lasts 24-36 hours. While using the sensor, the patient is required to wear (3) disposable electrodes to record their ECG. The monitor is approximately the size of a PDA device. It has a powerful microprocessor, extensive memory, imbedded algorithm, LCD display, wireless modem, and a global positioning system

(GPS). The monitor is powered by a rechargeable lithium battery, which typically lasts 18 hours. The monitors microprocessor is programmed to identify cardiac rhythm problems within guidelines established by the prescribing physician. The algorithm detection parameters and physician notification criteria are individualized for each patient and physician. Sensor with Lead Wires 4 CardioNet Monitor in Base The monitor continuously analyzes the ECG in real time as it is transmitted from the sensor. When an abnormal rhythm has been identified based on the monitoring parameters, the data is automatically sent via a wireless modem to the CardioNet Patient Service Center for additional review and interpretation by a certified monitoring specialist. In the case of a patient-initiated event, the monitor automatically prompts the patient to enter their symptoms and activities from a predetermined list on the touch screen display. When the patient is at home and an event occurs while the monitor is in the base, the patients normal telephone line is used to transmit the data. If an event occurs when the patient is in an area where cellular coverage is inadequate, the patient may elect to transmit their ECG directly, using a regular telephone. The base utilizes an AC power supply and is connected to the patients telephone line. The base also consists of two antennas, which allows the patient to have an expanded RF range within their home. When the patient is mobile, the RF range or leash length between the monitor and sensor is estimated to be 25-50 feet. The sensor and monitor are designed to alert the patient if and when they are out of RF range or cellular coverage. The CardioNet monitor has sufficient memory to store a minimum of twenty-four hours of the patients ECG. A daily protocol exists to upload the patients 24-hour ECG data, including related events and trends from the monitor to the Patient Service Center. 5 SERVICE OVERVIEW First, the prescribing physician is registered in the CardioNet service. All applicable contact and demographic data is collected and inputted into the CardioNet Patient Enrollment and Management System (PEMS) by a CardioNet representative. When a physician identifies a patient who is appropriate for CardioNet services, a patient enrollment is initiated by his/her office, included is patient demographics, insurance information, indications for usage, duration, thresholds, and medical necessity where applicable. Upon completion, the enrollment form is submitted to the Patient Service Center either by fax or Internet. For non Medicare patients, the physician practice may utilize the CPT code 93799-26 when billing for the professional interpretation, including the narrative description ECG arrhythmia detection and alarm system. An individual payor may establish or recommend alternative codes to be used to reflect the professional interpretation for CardioNet related services. The physician practice may wish to contact their provider representative to establish the appropriate billing requirements for CardioNet. Additionally, if you are currently required by the payor to provide a referral through the payor system you should continue to follow that procedure. Also if you are required to contact the payor for pre-

authorization/authorization to provide professional interpretation for diagnostic services continue to do so, this will also apply to CardioNet. When speaking to a payor or claims representative, it is important to note that CardioNet is not a Holter or event monitor. CardioNet mobile telemetry is a unique, proprietary technology and service offering, and is not the equivalent of any other monitoring technology or service. CardioNet will provide an in-home patient educator to train the patient on the use of the CardioNet System. CardioNet has a wealth of resources including in-home educators and print and video training tools to insure the highest level of patient confidence and compliance. Important CardioNet outpatient telemetry is a diagnostic service, not an emergency response service. It is possible, however, that a patient may develop a life-threatening arrhythmia while on our service. If we detect such an event, CardioNet will attempt to assist the patient in accessing EMS services. Physicians should be aware that our ability to assist ambulatory patients is limited by many factors including cell phone coverage, the inherent limitations of GPS locating technology and local EMS policies. 6 CardioNet provides a wealth of educational tools, including the Patient Education Guide, the Patient Pocket Guide, and a video. Monitoring Specialists Review and Interpret Data to Ensure Accuracy The CardioNet Patient Service Center is staffed with highly qualified and experienced cardiac monitoring specialists. At a minimum, all monitoring specialists are CCT certified. They have extensive experience in cardiovascular monitoring; including the hospital based C.C.U. and I.C.U. telemetry, emergency medical services, and other cardiac call center environments. As a Medicare provider, CardioNet is licensed as an Independent Diagnostic Testing Facility (IDTF). The CardioNet monitoring specialists serve a vital role in responding to patient and monitor initiated cardiac events. The monitoring specialists provide a thorough preliminary analysis of the patients ECG to insure that the data is accurate and presented in the appropriate time and manner as requested by the physician. All calls are monitored and recorded for quality assurance. CardioNet requires that all monitoring specialists participate in additional training and educational programs. A continuous QA process has been established for all facets of the service center operation. The monitoring specialists, based on defined physician guidelines, prepare daily patient summary reports for final physician review and interpretation. In the case of a patient notification threshold event, the prescribing physician is contacted immediately and an urgent report is submitted for review and interpretation. Reports are tailored to the needs and requirements of the physician and are sent via the Internet, facsimile, or standard mail. The CardioNet Patient Service Center is fully staffed and available 7x24, 365 days of the year. 7 PATIENT ENROLLMENT The Patient Enrollment Form is located in the CardioNet Patient Enrollment and Management System (PEMS). The client can access the CardioNet Patient Enrollment and Management System application at www.cardionet.com. This is a secure and restricted website and the user is required to be enrolled as a CardioNet client. Forms are also available from the CardioNet Patient Service Center. If you are not a CardioNet registered user, please contact the Patient Service Center. Please enter your username and password to log in. Username Password Login Log in to access the CardioNet Patient Enrollment and Management System. After you have entered your user name and password, click the log in button on your screen. You now have access to the CardioNet Patient Enrollment and Management System. The name of the client, physician or practice should appear on the upper left of the PEMS application. You may also refer to the CardioNet Quick Start Guide for instructions on enrolling a patient. Using the CardioNet navigational tree on the left side, click on Documents and Forms. A document tab will open with a list of applicable forms. Click on Patient Enrollment Form (MON300) and print a copy. Follow the same process and procedure for Patient Prescription Form (MON302). Each form must be completed to enroll a patient on CardioNets service. The Patient Enrollment Form includes patient demographics, emergency information, primary and secondary insurance, patient waiver and assignment of benefits. Using this form please input all the appropriate information in the fields listed. In addition to any insurance information that is listed on the form, please provide CardioNet with a copy (front and back) of the patients insurance card. The patients signature is required on all enrollment forms prior to submitting to CardioNet. 8 The Patient Prescription Form includes the patient name, prescribing physician, physician group name, and duration of monitoring requested, diagnosis and ICD-9 code. Using this form input all the appropriate information in the fields listed. The prescribing physician is required to sign the CardioNet Patient Prescription Form prior to enrolling the patient. Please fax both completed forms, including a copy of the patients insurance card to the CardioNet Patient Service Center. The enrollment information will be entered into the CardioNet patient database; the patients insurance carrier will be contacted for preauthorization as required, upon approval, the delivery of the CardioNet System will be scheduled as soon as possible. Please see Sample Forms and Reports section of this manual for examples of reports and forms. 9 ELECTRONIC PATIENT ENROLLMENT CardioNet provides an additional method for enrolling patients in our service, electronic enrollment. If the user prefers to use CardioNets electronic enrollment process, you can access the CardioNet Patient Enrollment and Management System (PEMS) application at www.cardionet.com. Use the Physician Log In and enter the username and password, and then click on Enroll Patient. The application will open to Patient Demographics. Please be advised that all fields and applicable tabs (Emergency and Insurance Information) must be completed prior to submitting an electronic enrollment. Note: Electronic Patient Enrollment is not currently an active application in PEMS. Enroll Patient Online 10 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTOR Indications for Use 1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia 2. Patients with dizziness or light-headedness 3. Patients with palpitations 4. Patients with syncope of unknown etiology 5. Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. This includes postoperative monitoring for these rhythms 6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias 7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease 8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias 9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation 10. Data from the device may be used by another device to analyze measure or report QT interval. The device is not intended to sound any alarms for QT interval changes. Contraindications 1. Patients who have a history of sustained ventricular tachycardia or a documented occurrence of ventricular fibrillation 2. Patients who the attending physician thinks will be at risk for ventricular tachycardia or ventricular fibrillation as indicated by the following:

! A measured ejection fraction of less than 35% with complex ventricular ectopic activity (>= 10 PVCs per hour or repetitive PVCs)

! Unstable angina defined as chest pain at rest, a new onset of angina, or a change in existing patterns of angina

! Patients with a recent (<= 3 months) myocardial infarction (MI)

! Patients who are candidates for or have had recent heart valve surgery 3. Patients who the attending physician thinks should be hospitalized. 11 REPORTS When a physician group and/or physician is enrolled in CardioNets service, preferred reporting methods for different events (Internet, fax, mail or telephone) are established for each physician user. Physicians may elect to modify or change their preferred report delivery methods by selecting Modify Physician in the CardioNet Patient Enrollment and Management System, or contacting the CardioNet Patient Service Center directly. Fax or mail reports are forwarded to the physician by the CardioNet Patient Service Center. To access Patient Reports using PEMS, the user must log in to www.cardionet.com. . . . . Use the Physician Log In, and enter the user name and password. The name of the physician practice or physician will appear in the top left of your screen. Using the navigational tool bar on the left side, please click on Active Patients. A list of all active patients will appear under the Patient Reports tab. Included with a list of active patients will be the type of report, date of report, report delivery method, time and date the report was sent from the Patient Service Center, and a confirmation to indicate that the user has either read or needs to review the report listed. To select a patient report you wish to review, click on the patients name. Note: The user must have Adobe Acrobat Reader in order to view and print a CardioNet patient report. CardioNet provides reports for physician review, such as the:

Urgent Notification Mobile Telemetry and Daily Mobile Telemetry. An Urgent Report is provided to the physician when a patient has an event, symptomatic or asymptomatic, that meets the physician defined notification threshold. The Daily Report is provided to the prescribing physician for each day the patient is on service with CardioNet. The Daily Report includes a heart rate trend graph and selected patient events for the previous 24-hour period. 12 A Representative ECG for the Urgent Report The Urgent Report provides a six second sample of the patients ECG, Channel 1 and 2. The report includes a time and date stamp of the actual event, preliminary findings of the CardioNet monitoring specialist, symptoms and activities reported by the patient, and how the event was initiated, automatic or patient initiated. Note: The Patient Service Center has an established procedure for contacting the prescribing physician in advance of receiving an Urgent Notification Mobile Telemetry Report. Escalation and notification protocols have been approved by the Patient Center Medical Director to deal with Emergency, Urgent, and Daily patient events. Refer to Physician Notification Order Form (MON305). Each client or physician as part of the CardioNet enrollment process is responsible for providing appropriate contact numbers for normal business hours, after hours, weekends and holidays. The client or physician user can request additional ECG data from the Patient Service Center to support a particular event or report. Please see Sample Forms and Reports section of this manual for examples of reports and forms. 13 PHYSICIAN NOTIFICATION As part of the CardioNet client enrollment process, the Physician Notification criteria will be established for the client (physician practice) or individual prescribing physician. The Physician Notification Order Form (MON305) is to be completed and signed prior to enrolling a patient on CardioNets service. CardioNets Medical Advisory Board provides a set of default values based on established clinical practice monitoring guidelines. An Emergency notification threshold cannot be downgraded for physician notification purposes. The physician may elect to change or modify an Urgent or Daily patient event threshold to a higher priority notification. Please see Sample Forms and Reports section of this manual for examples of reports and forms. Modifying Physician Notification A physician may request that the notification criteria be changed or modified for a particular patient at the time a patient is enrolled or during the course of monitoring. If the patient is being actively monitored, the client must complete and sign a Physician Notification Change Order (MON306). Upon receipt of the form by the Patient Service Center, it will be reviewed and approved by a clinical manager. The change will be noted in the patients medical record and the monitor will be reconfigured to reflect the change where applicable. The Patient Prescription Form (MON302) should be used when enrolling a new patient on the CardioNet service. Refer to Patient Enrollment. 14 BILLING The patient is responsible for providing the CardioNet Patient Service Center with all applicable insurance information at the time of enrollment. CardioNet will bill the patients primary insurance company. In addition, CardioNet will also bill the secondary insurance company, if provided by the patient. A copy of the patients insurance card is to be provided with the enrollment. The patient/responsible party/legal guardian is required to sign the Patient Enrollment Form. CardioNet will bill the insurance company for only those services provided directly by CardioNet to the patient. In most cases, this is defined as the technical component, which includes monitoring and all equipment required to monitor the patient. The physician is responsible for billing the patients insurance carrier for the professional component, which is defined as the physician interpretation. Insurance Verification and Benefit CardioNet requires that a patients insurance coverage is confirmed and benefits are verified. If the insurance verification determines that services requires a pre-authorization CardioNet takes the appropriate step to comply with the insurance company. It is imperative that the Physician always complies with the requirements of the Insurance Company regarding the referral process and subsequent pre-

authorization/authorization as determined by the patient/members benefit plan. If additional information (certificate of medical necessity, etc.) by the insurance company is required to obtain authorization, CardioNet will immediately contact the prescribing physician. If CardioNet is not able to obtain authorization from the insurance company to provide services for the patient, the prescribing physician and patient will be notified immediately. The patient may then elect to continue on service with CardioNet, and therefore would assume 100%

financial responsibility for all related charges. CardioNet has established an appropriate set-up and technical fee for Mobile Cardiac Outpatient Telemetry. Medicare in the state of Pennsylvania established a new policy (M-60) on February 11, 2002, to address Real-Time Cardiac Surveillance System. Please review the LMRP M-60 policy description, indications and limitations, and/or medical necessity. 15 Physician Reimbursement Coding Guidelines The LMRP determined that no existing CPT code fully and accurately describes this new technology; therefore services should be reported by using CPT Code 93799 and include the narrative ECG arrhythmia detection and alarm system. Providers are instructed to bill one (1) unit of procedure code 93799, per day of cardiac surveillance. The TC (Technical) and 26 (Professional) modifiers should be used with CPT Code 93799 to identify what component of the monitoring was performed. The Professional Component includes review and interpretation of each 24-hour cardiac surveillance as well as 24-hour availability and response to surveillance events. CardioNet, based on relevant policies and procedures from all non-

Medicare insurance providers, will bill for its services in a similar manner, unless otherwise instructed. Patient Responsibility CardioNet has established an initial set-up and technical fee for Mobile Cardiac Outpatient Telemetry. CardioNet will bill the patients insurance company for the intended service duration as defined by the prescribing physician. In certain instances, the patients insurance company may regard CardioNet as an out of network provider. It is not our intent to penalize the patient if their insurance company regards CardioNet as an out of network provider. CardioNet will continue to bill and collect from the patient all applicable co-payments and deductibles. CardioNet will make every reasonable effort to insure that the patients financial responsibility will not exceed their normal in plan benefits. With the exception of Medicare, CardioNet will obtain insurance pre-authorization for all services to be provided by CardioNet. All services will be billed to the applicable parties upon completion of the prescribed service period, or upon discontinuation of service as requested by the physician, patient, or insurance company. 16 PRECAUTIONS Dispose of Batteries Properly Observe all local laws for the disposal of alkaline batteries. When Not in Use, Remove Sensor Battery Do not leave the battery in the sensor when it is not in use. Damage from corrosion could result. Avoid Electromagnetic Interference For the best recording results, you should avoid close proximity to heavy equipment or other sources of electromagnetic interference such as electric blankets, heating pads, water beds, etc. Potential for Electromagnetic Interference There is a potential for electromagnetic interference to other devices while using the CardioNet service. The CardioNet system with implanted pacemakers and ICDs (defibrillators) If you have an implanted pacemaker or defibrillator (ICD), the manufacturer may have recommended you take certain precautions when using a cellular phone. Since the CardioNet monitor contains a cellular phone, you should take the same precautions when carrying and using the monitor. In general, most manufacturers recommend the following:

! Keep a distance of at least six inches (15 cm) between the cellular phone and a pacemaker or defibrillator.

! Hold the cellular phone on the opposite side of the body from the pacemaker or defibrillator.

! Dont carry a cellular phone in a breast pocket or on a belt if that would place the phone within six inches of the pacemaker or defibrillator. 17 CAUTIONS AND WARNINGS Caution: Power Down and Remove Sensor Before Showering Power down the monitor and remove the sensor before showering. While the CardioNet sensor and monitor are water resistant, they are not waterproof. Refer to the Patient Education Guide for complete instruction on removal and reapplication before showering. Caution: Do Not Get the Monitor and Sensor Wet Make sure the monitor and sensor stay dry at all times. Warning: For Adult Use Only The CardioNet Monitoring System is intended for Adult use only. It shall not be used on infants weighing less than 22 lbs. Warning: Use with Telephone System Any patient whose life may be put at significant risk by the unavailability of the telephone system should not be monitored by the CardioNet System. Warning: Not an Apnea Monitor The CardioNet monitor is not to be used as an apnea monitor. Warning: Use Only CardioNet Electrodes While wearing the CardioNet sensor, use only electrodes provided by CardioNet. Warning: Do Not Tamper There are no serviceable parts in the CardioNet System. Removing the cover of any of component may alter performance. Warning: Do Not Tamper with Monitor Battery The monitor battery can present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 80C (176 F), incinerate, or recharge using any device other than the base. Warning: Use Only CardioNet Wall Adapter Do not use any wall adapter for the base other than the one provided in the CardioNet Service Kit. Warning: Do Not Connect Any Device to the PC Port on the Back of the Base The PC port is to be used only by CardioNet personnel. 18 TECHNICAL SPECIFICATIONS Physical Sensor 2.7 in. x 0.9 in height Weight: 2.2 oz Sensor neck strap 24 in. Monitor 5.8 in x 3.0 in x 1.1 in Weight: 12.8 oz LCD 3.0 x 2.3, touch screen, monochrome, backlight Base 7.8 in x 4.3 in x 6.1 in Weight: 13.3 oz Functional 250 samples per second 12 bits Sample Rate Resolution Dynamic Range + / -5 mV Bandwidth Channels Battery Life 0.5 to 40 Hz 2 Monitor: (12-16 hours average with cleared memory and fully recharged battery), rechargeable Sensor:

(24 hr) AA Alkaline Leakage current Less than .1 V Electrodes Transmission Sensor to Monitor 900 MHz ISM band RF transmission, digital error cor-

rected. 30 foot range, retransmission if data is corrupted. Monitor to Center CDMA (PCS & cellular) wireless, digital error corrected. Telephone line modem, digital error corrected. Acoustic transmission, 1500 Hz center frequency, 8 bits resolution, 5 mV dynamic range. ECG recording intervals vary by type of event; the minimum is 15 seconds pre-event and 45 seconds post event. Wireless transmission subject to coverage of cellular network. Data received at Monitoring Center within minutes with good wireless coverage and/or modem communications. Urgent reports processed at time of data receipt. Daily reports processed once a day, by 3 PM. 19 Operating conditions Operating temperature Operating humidity Storage temperature Storage humidity Operation altitude Fluid Ingress Rating Note: Please protect the monitor and sensor from water and other fluids. 20 - 45 o C 10% - 95%, noncondensing

-20 - 55 o C, noncondensing 5% - 95%, noncondensing 700-1060 millibars IPX1 Connectors Base Monitor Wall Adapter Manufacturer Model number Power in (15V, 1.2A max) Phone in (RJ-11) Phone out (RJ-11) Power in (15V, 1.2A max) Friwo, Inc. (15V, 1.0A) FW7555M/15 Note: Both the Monitor and Sensor are internally powered continuous operation devices. 20 Standards Compliance Monitor Sensor Base EN60601-1 AAMI EC-38 FCC parts 2, 15, 22, 24 EN60601-1 AAMI EC-38 FCC part 15 EN60950 AAMI EC-38 FCC part 15, 68 AECG Equipment Class II Note: This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1993, EN60601-1-2:1994, Medical Device Directive 93/42/EEC or the Electromagnetic Compatibility Directive 89/336/EEC (use applicable directive). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

! Reorient or relocate the receiving device.

! Increase the separation between the equipment.

! Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

! Consult the manufacturer or field service technician for help UL Listed The CardioNet monitor and base have been tested to UL 2601, No. EN60601-1. The CardioNet base is compliant with EN60950. 21 EQUIPMENT SYMBOLS Consult Manual Year of Manufacture 2000 Type BF Equipment SN Serial Number HARDWARE REQUIREMENTS In Home Requirements Touch tone telephone AC powered outlet FCC ID Sensor Monitor Monitor cell Base QBI-1007 QBI-1006 NBZNRM-6832 CARDT00B42061 22 ARRYTHIMIA DETECTION ALGORITHM PERFORMANCE ANALYSIS The CardioNet System incorporates an arrhythmia analysis algorithm whose performance is presented below:

The algorithm results were obtained from the respective databases in strict accordance with EC-57 and with 0% downtime on both databases. Performance Measure QRS Detection Sensitivity %

QRS Detection Positive Predictivity %

PVC Detection Sensitivity %

PVC Detection Positive Predictivity %

PVC Detection False Positive Rate %

MIT Arrhythmia Database 99.93 99.85 95.44 96.94 0.229 AHA Database 99.88 99.89 94.07 97.72 0.222 23 HEART RATE MEASUREMENT REPORT The performance of the analysis algorithm for heart rate detection on standard databases is shown below. The average RMS errors for the AHA, MIT-arrhythmia, and NST databases are 2.08%, 1.07%, and 30.9% respectively. Heart Rate Calculation The average heart rate is calculated by computing the mean of the actual RR-intervals, in the last 6 seconds or 8 RR-intervals (whatever is shorter). The actual RR intervals are calculated based on the QRS detected events:

Actual RR = the time between the last detected QRS complex and the previously detected QRS complex, in milliseconds In the CardioNet reports, the heart rate displayed on the ECG strips themselves is the average of the rate for the beats displayed in that strip. AHA ECG Database (Summary of results from 78 records) ErrSum 130111.6913 RefSu 2167402.8283 Nmeas 26706 MeanRefHR RMSerror(%) 81.15792.7197 81.4511 2.7197 2.0762 Sum Gross Average MIT-BIH Arrhythmia Database (Summary of results from 44 records) ErrSum 25694.4788 RefSu 1016331.6122 Nmeas 13030 MeanRefHR RMSerror(%) 77.9994 78.0769 1.8003 1.0691 Sum Gross Average NST Database (Summary of results from 12 records) ErrSum 3098725.4772 RefSu 266364.2826 Nmeas 3576 MeanRefHR RMSerror(%) 74.4867 74.4867 39.5198 30.8921 Sum Gross Average 24 RUN-BY-RUN REPORT AHA ECG Database Record Sum Gross Average CTs CFN CTp CFP STs SFN STp SFP LTs 904 95 1048 35 26 379 85 487 12 Total couplets: 999 Total short runs: 464 Total long runs: 79 LFN LTp LFP CSe C+P SSe S+P LSe L+P 53 75 4 90 72 97 78 82 55 98 97 33 76 95 91 MIT-BIH Arrhythmia Database Record Sum Gross Average CTs CFN CTp CFP STs SFN STp SFP LTs 564 84 10 575 35 32 20 42 5 LFN LTp LFP CSe C+P SSe S+P LSe L+P 3 15 0 87 78 94 74 62 60 89 87 77 78 100 100 Total couplets: 648 Total short runs: 52 Total long runs: 13 VENTRICULAR FIBRILLATION EPISODE REPORT AHA VF Detection Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration Sum 9 1:28:50.140 1:10:59.646 Gross Average Summary of results from 78 records 100 100 100 100 26 0 79 77 99 96 0 MIT-BIH Detection Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration Sum 1 Gross Average Summary of results from 44 records 1:37.900 1:44.032 100 100 100 100 91 92 86 86 0 1 0 CU Detection Record TPs FN TPp FP ESe E+P DSe D+P Ref duration Test duration Sum 26 5 Gross Average Summary of results from 30 records 40:38.772 24:55.332 93 53 86 96 52 76 84 87 28 2 PACEMAKER DETECTION RESULTS Pacemaker detection:

Meets AAMI EC38 25 FCC and Industry Canada (CS-03) Compliance This device complies with part 15 and 68 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 interference received including interference that may cause undesired operation. FCC Rules Part 15 The Model 1001 has been tested and complies with the limits for a class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, can cause harmful interference to radio communications. CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY CardioNet Inc. COULD VOID THE USERS AUTHORITY TO OPERATE THE EQUIPMENT. FCC Rules Part 68 FCC Part 68 Registration The Model 1001 complies with FCC Rules, Part 68. On this equipment is a label that contains, among other information, the FCC Part 68 registration number. REN The ringer equivalence number (REN) is used to determine the quality of devices that may be connected to the telephone line. Excessive RENs on the telephone line may result in the devices not ringing in response to an incoming call. In most, but not all areas, the sum of RENs should not exceed five (5.0). To be certain of the number of devices that may be connected to a line, as determined by the total RENs, contact the local telephone company. Note: RENs are associated with loop-start and ground-start ports. It is not used for E&M and digital ports. The REN assigned to the Model 1001 is 0.01 B. If requested, this information must be given to the telephone company. 26 Service In the event of equipment malfunction, all repairs should be performed by CardioNet Inc. or an authorized agent. It is the responsibility of users requiring service to report the need for service to CardioNet Inc. or to one of our authorized agents. Service can be facilitated through our office at:

CardioNet Inc. 510 Market St. San Diego, CA 92101 619-243-7500 The telephone company can ask you to disconnect the equipment from the network until the problem is corrected or until you are sure that the equipment is not malfunctioning. The Model 1001 interface connects to the Public Switched Telephone Network through a FCC registered NCTE which specifies the type of network jack to be used. Disruption of the Network If the Model 1001 disrupts the telephone network, the telephone company can discontinue your service temporarily. If possible, the telephone company will notify you in advance. If advance notice is not practical, they will notify you as soon as possible. You are also informed of your right to file a complaint with the FCC. Telephone Company Facility Changes The telephone company can make changes in its facilities, equipment, operations, or procedures that can affect the operation of your equipment. If they do, you should be notified in advance so you have an opportunity to maintain uninterrupted telephone service. FCC RADIO FREQUENCY EXPOSURE INFORMATION In August 1996, the Federal Communication Commission (FCC) of the United States, with its action in Report and Order FCC 96-326, adopted an updated safety standard for human exposure to radio frequency (RF) electromagnetic energy emitted by FCC regulated transmitters. Those guidelines are consistent with the safety standard previously set by both U.S. and international standards bodies. The design of this device complies with the FCC guidelines and these international standards. Use only the supplied antenna. Unauthorized antennas, damaged antennas, modifications, or attachments could impair call quality, damage the device, or result in violation of FCC regulations. Please contact CardioNet if damage to the unit is apparent. 27 BODY-WORN OPERATION This device was tested with the softcase sup-

plied by CardioNet as an accessory to this device and was found to comply with the FCC exposure requirements. When operating this device, a minimum separation distance of 1.5 cm must be maintained between the users body and the monitor, including its antenna, to comply with the FCC exposure limits. To maintain compliance with FCC RF exposure requirement, use only carrying accessories that maintain a 1.5 cm separation distance between the users body and the device, including the antenna. These carrying accessories should not contain metallic components in its assembly. The use of carrying accessories that do not satisfy these requirements may not comply with FCC RF exposure requirements, and should be avoided. This particular device has not been designed for held-to-ear use and should never be used against the ear. For more information about RF exposure, please visit the FCC website at www.fcc.gov . 28 SAMPLE FORMS AND REPORTS Examples of the forms listed below follow.

! Patient Enrollment Form

! Physician Enrollment Form

! Client Enrollment Form

! Patient Prescription Form

! Physician Notification Orders Form

! Physician Notification Change Orders Form

! Daily Mobile Report

! Urgent Mobile Telemetry Report

! End of Service Report To access electronic versions of forms and reports, log on to www.cardionet.com..... 29